Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

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• Detailed Descriptions
• XML
• JSON

Resource Profile: BatchFormula - XML Profile

XML representation of the pqcmc-product-batch-formula resource profile.

Raw xml | Download

<StructureDefinition xmlns="http://hl7.org/fhir">
  <id value="pqcmc-product-batch-formula"/>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: StructureDefinition pqcmc-product-batch-formula</b></p><a name="pqcmc-product-batch-formula"> </a><a name="hcpqcmc-product-batch-formula"> </a><a name="pqcmc-product-batch-formula-en-US"> </a><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the element can appear in the instance">Card.</a></th><th style="width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description &amp; Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_resource.png" alt="." style="background-color: white; background-color: inherit" title="Resource" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition">ManufacturedItemDefinition</a><a name="ManufacturedItemDefinition"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/manufactureditemdefinition.html">ManufacturedItemDefinition</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.identifier">identifier</a><a name="ManufacturedItemDefinition.identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span>..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">optional user designated identifier</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.status">status</a><a name="ManufacturedItemDefinition.status"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">draft | active | retired | unknown</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.name" title="A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional. [Source: SME Defined]">name</a><a name="ManufacturedItemDefinition.name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Product Non-proprietary Name</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.manufacturedDoseForm">manufacturedDoseForm</a><a name="ManufacturedItemDefinition.manufacturedDoseForm"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Dose form as manufactured (before any necessary transformation)</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-manufactured-dose-form-terminology.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology">Manufactured Dose Form Terminology</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.manufacturer">manufacturer</a><a name="ManufacturedItemDefinition.manufacturer"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-literal-reference.html" title="Literal Reference">LiteralReference</a>(<a href="StructureDefinition-cmc-organization.html">Basic Organization</a>)<a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html"> {</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html" title="When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.">b</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html">}</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Manufacturer of the item, one of several possible</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="." style="background-color: white; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property">Slices for property</a><a name="ManufacturedItemDefinition.property"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic"/><span style="font-style: italic">2</span><span style="font-style: italic">..</span><span style="opacity: 0.5; font-style: italic">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5; font-style: italic">General characteristics of this item</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Closed by value:type.text</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck133.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> property:All Slices<a name="ManufacturedItemDefinition.property.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Content/Rules for all slices</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1321.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property.type">type</a><a name="ManufacturedItemDefinition.property.type"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">A code expressing the type of characteristic</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13200.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property.type.text">text</a><a name="ManufacturedItemDefinition.property.type.text"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Plain text representation of the concept</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property:BatchSize" title="Slice BatchSize: The amount of material in a specific batch size [Source: SME Defined]
Example: 1000 kg">property:BatchSize</a><a name="ManufacturedItemDefinition.property.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Batch Quantity</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property:BatchSize.type">type</a><a name="ManufacturedItemDefinition.property.type.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13500.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property:BatchSize.type.text">text</a><a name="ManufacturedItemDefinition.property.type.text.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Plain text representation of the concept</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">Batch Quantity</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1341.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property:BatchSize.value[x]">value[x]</a><a name="ManufacturedItemDefinition.property.value_x_"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Quantity">Quantity</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">A value for the characteristic</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-units-of-measure.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure">Units Of Measure</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13410.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property:BatchSize.value[x].value">value</a><a name="ManufacturedItemDefinition.property.value_x_.value"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#decimal">decimal</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Numerical value (with implicit precision)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13400.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property:BatchSize.value[x].code" title="A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI EVS - C25709]">code</a><a name="ManufacturedItemDefinition.property.value_x_.code"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Quantity UOM</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property:BatchUtil" title="Slice BatchUtil: A categorization of the batch that identifies its usage. [Source: SME Defined]
Examples: commercial, development.">property:BatchUtil</a><a name="ManufacturedItemDefinition.property.4"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Batch Utilization<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property:BatchUtil.type">type</a><a name="ManufacturedItemDefinition.property.type.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13500.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property:BatchUtil.type.text">text</a><a name="ManufacturedItemDefinition.property.type.text.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Plain text representation of the concept</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">Batch Utilization</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property:BatchUtil.value[x]">value[x]</a><a name="ManufacturedItemDefinition.property.value_x_.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">A value for the characteristic</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-batch-utilization-terminology.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology">Batch utilization Terminology</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property:AddInfo" title="Slice AddInfo: A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying.
Implementation note: This is represented in  markdown.  For multiple comments utilize markdwon formating for separation of notes.">property:AddInfo</a><a name="ManufacturedItemDefinition.property.5"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Batch Formula Additional Information</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1251.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property:AddInfo.type">type</a><a name="ManufacturedItemDefinition.property.type.4"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck12500.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property:AddInfo.type.text">text</a><a name="ManufacturedItemDefinition.property.type.text.4"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Plain text representation of the concept</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">Product Part Additional Information</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1240.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property:AddInfo.value[x]">value[x]</a><a name="ManufacturedItemDefinition.property.value_x_.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#markdown">markdown</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">A value for the characteristic</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component">component</a><a name="ManufacturedItemDefinition.component"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.type" title="Identifies the kind of element, based on the design the applicant develops to achieve the desired drug product and overall release profile. [Source: SME Defined]
Example: Layer, Bead, Minitablet, Capsule Shell, Coating">type</a><a name="ManufacturedItemDefinition.component.type"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Product Part Type<br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-product-part-type.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type">Product Part Type Terminology</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck013.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="." style="background-color: white; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.amount">Slices for amount</a><a name="ManufacturedItemDefinition.component.amount"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic"/><span style="font-style: italic">2</span><span style="font-style: italic">..</span><span style="font-style: italic">2</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R5/datatypes.html#Quantity">Quantity</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5; font-style: italic">The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Closed by value:code</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.amount:perBatch" title="Slice perBatch: Specifies the amount of the component per batch size of the drug product. [Source: SME Defined]">amount:perBatch</a><a name="ManufacturedItemDefinition.component.amount.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Quantity">Quantity</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Component Quantity Per Batch</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.amount:perBatch.value">value</a><a name="ManufacturedItemDefinition.component.amount.value"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#decimal">decimal</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Numerical value (with implicit precision)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.amount:perBatch.unit">unit</a><a name="ManufacturedItemDefinition.component.amount.unit"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Unit representation</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.amount:perBatch.code">code</a><a name="ManufacturedItemDefinition.component.amount.code"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Coded form of the unit</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-non-percentage-units.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units">Non-Percentage Units</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0125.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.amount:percent" title="Slice percent">amount:percent</a><a name="ManufacturedItemDefinition.component.amount.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Quantity">Quantity</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01250.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.amount:percent.value">value</a><a name="ManufacturedItemDefinition.component.amount.value.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#decimal">decimal</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Numerical value (with implicit precision)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01250.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.amount:percent.unit">unit</a><a name="ManufacturedItemDefinition.component.amount.unit.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Unit representation</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01240.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.amount:percent.code">code</a><a name="ManufacturedItemDefinition.component.amount.code.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Coded form of the unit</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-percentage-units.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units">Percentage Units</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.constituent">constituent</a><a name="ManufacturedItemDefinition.component.constituent"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0113.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.constituent.extension">Slices for extension</a><a name="ManufacturedItemDefinition.component.constituent.extension"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.constituent.extension:additional-info" title="Extension URL = http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension">additional-info</a><a name="ManufacturedItemDefinition.component.constituent.extension.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#markdown">markdown</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Drug Product Constituent Additional Information<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-pq-additional-info-extension.html">http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension</a></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.constituent.extension:formulaIngredient" title="Extension URL = http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension">formulaIngredient</a><a name="ManufacturedItemDefinition.component.constituent.extension.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">(Complex)</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Product Batch Ingredient Extension</span><br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-pq-product-batch-ingredient-extension.html">http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension</a></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01124.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.constituent.extension:StrengthTextual" title="Extension URL = http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension">StrengthTextual</a><a name="ManufacturedItemDefinition.component.constituent.extension.4"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Product Batch Strength Textual Extension</span><br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-pq-product-batch-strength-textual-extension.html">http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension</a></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0113.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="." style="background-color: white; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.constituent.amount">Slices for amount</a><a name="ManufacturedItemDefinition.component.constituent.amount"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic"/><span style="font-style: italic">2</span><span style="font-style: italic">..</span><span style="font-style: italic">2</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R5/datatypes.html#Quantity">Quantity</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5; font-style: italic">The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Closed by value:code</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.constituent.amount:perBatch" title="Slice perBatch: Specifies the amount of the component per batch size of the drug product. [Source: SME Defined]">amount:perBatch</a><a name="ManufacturedItemDefinition.component.constituent.amount.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Quantity">Quantity</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Component Quantity Per Batch</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.constituent.amount:perBatch.value">value</a><a name="ManufacturedItemDefinition.component.constituent.amount.value"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#decimal">decimal</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Numerical value (with implicit precision)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.constituent.amount:perBatch.unit">unit</a><a name="ManufacturedItemDefinition.component.constituent.amount.unit"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Unit representation</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.constituent.amount:perBatch.code">code</a><a name="ManufacturedItemDefinition.component.constituent.amount.code"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Coded form of the unit</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-non-percentage-units.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units">Non-Percentage Units</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01125.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.constituent.amount:percent" title="Slice percent: Quantity expressed as Volume To Volume: The percentage of the component in the batch [Source: SME Defined]
Quantity UOM: A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI E - C25709]">amount:percent</a><a name="ManufacturedItemDefinition.component.constituent.amount.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Quantity">Quantity</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Quantity Percent</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011250.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.constituent.amount:percent.value">value</a><a name="ManufacturedItemDefinition.component.constituent.amount.value.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#decimal">decimal</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Numerical value (with implicit precision)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011250.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.constituent.amount:percent.unit">unit</a><a name="ManufacturedItemDefinition.component.constituent.amount.unit.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Unit representation</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011240.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.constituent.amount:percent.code">code</a><a name="ManufacturedItemDefinition.component.constituent.amount.code.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Coded form of the unit</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-percentage-units.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units">Percentage Units</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.constituent.location" title="Identifies where the ingredient physically resides within the product part. [Source: SME Defined]
Examples: Intragranular, Extra granular, Blend">location</a><a name="ManufacturedItemDefinition.component.constituent.location"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Product Part Ingredient Physical Location<br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-pqcmc-product-part-ingredient-physical-location.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location">Ingredient Location Terminology</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.constituent.hasIngredient">hasIngredient</a><a name="ManufacturedItemDefinition.component.constituent.hasIngredient"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-literal-codeable-reference.html" title="Literal Coded Reference">LiteralCodeableReference</a>(<a href="StructureDefinition-pqcmc-dp-ingredient.html">Drug Product Batch Formula Ingredient</a>)<a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html"> {</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html" title="When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.">b</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html">}</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Reference to a resource or a concept</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck013.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.property">Slices for property</a><a name="ManufacturedItemDefinition.component.property"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic"/><span style="font-style: italic">1</span><span style="font-style: italic">..</span><span style="opacity: 0.5; font-style: italic">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="font-style: italic" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5; font-style: italic">General characteristics of this component</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Closed by value:type.text</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0133.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> property:All Slices<a name="ManufacturedItemDefinition.component.property.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Content/Rules for all slices</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01321.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.property.type">type</a><a name="ManufacturedItemDefinition.component.property.type"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">A code expressing the type of characteristic</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck013200.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.property.type.text">text</a><a name="ManufacturedItemDefinition.component.property.type.text"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Plain text representation of the concept</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.property:PPiD" title="Slice PPiD: A submitter designated identifier that uniquely identifies the part within the drug product. [Source: SME Defined]
Examples: 1, A1, Red bead, Blue minitablet">property:PPiD</a><a name="ManufacturedItemDefinition.component.property.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Product Part Identifier</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.property:PPiD.type">type</a><a name="ManufacturedItemDefinition.component.property.type.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck013500.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.property:PPiD.type.text">text</a><a name="ManufacturedItemDefinition.component.property.type.text.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Plain text representation of the concept</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">Product Part Identifier</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.property:PPiD.value[x]">value[x]</a><a name="ManufacturedItemDefinition.component.property.value_x_"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-codeable-concept-text-only.html" title="CodeableConcept">CodeableConceptTextOnly</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Concept - reference to a terminology or just  text</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.property:PPiDref" title="Slice PPiDref: Identifies the parent or outer-level product part. [Source: SME Defined]
Example: A bead (Product Part Identifier = “B1”) has a seal coating (Product Part Identifier = “SCoat”) and is contained in a Hard HPMC capsule shell (Product Part Identifier “Cap Shell”). For the seal coating, Product Part Identifier Reference = “B1”, because the seal coat is applied to the bead.">property:PPiDref</a><a name="ManufacturedItemDefinition.component.property.4"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Product Part Identifier Reference</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.property:PPiDref.type">type</a><a name="ManufacturedItemDefinition.component.property.type.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck013500.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.property:PPiDref.type.text">text</a><a name="ManufacturedItemDefinition.component.property.type.text.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Plain text representation of the concept</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">Product Part Identifier Reference</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.property:PPiDref.value[x]">value[x]</a><a name="ManufacturedItemDefinition.component.property.value_x_.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-codeable-concept-text-only.html" title="CodeableConcept">CodeableConceptTextOnly</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Concept - reference to a terminology or just  text</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0125.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.property:AddInfo" title="Slice AddInfo: A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying.
Implementation note: This is represented in  markdown.  For multiple comments utilize markdwon formating for separation of notes.">property:AddInfo</a><a name="ManufacturedItemDefinition.component.property.5"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Product Part Additional Information</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01251.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.property:AddInfo.type">type</a><a name="ManufacturedItemDefinition.component.property.type.4"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck012500.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.property:AddInfo.type.text">text</a><a name="ManufacturedItemDefinition.component.property.type.text.4"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Plain text representation of the concept</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">Product Part Additional Information</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01240.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.property:AddInfo.value[x]">value[x]</a><a name="ManufacturedItemDefinition.component.property.value_x_.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#markdown">markdown</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">A value for the characteristic</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.component.component">component</a><a name="ManufacturedItemDefinition.component.component"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">A component that this component contains or is made from</span></td></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <url
       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.40.36.42.47"/>
  </identifier>
  <version value="2.0.0-ballot"/>
  <name value="BatchFormula"/>
  <title value="Drug Product Batch Formula"/>
  <status value="active"/>
  <date value="2024-12-04T20:50:29+00:00"/>
  <publisher value="HL7 International / Biomedical Research and Regulation"/>
  <contact>
    <name value="HL7 International / Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="brr@lists.HL7.org"/>
    </telecom>
  </contact>
  <description
               value="Listing of all components of the dosage form to be used in the manufacture, their amounts on a per batch basis, including overages, and reference to their quality standards."/>
  <jurisdiction>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="US"/>
      <display value="United States of America"/>
    </coding>
  </jurisdiction>
  <fhirVersion value="5.0.0"/>
  <mapping>
    <identity value="w5"/>
    <uri value="http://hl7.org/fhir/fivews"/>
    <name value="FiveWs Pattern Mapping"/>
  </mapping>
  <mapping>
    <identity value="idmp"/>
    <uri value="https://www.iso.org/obp/ui/#iso:std:iso:11615"/>
    <name value="IDMP Mapping"/>
  </mapping>
  <mapping>
    <identity value="rim"/>
    <uri value="http://hl7.org/v3"/>
    <name value="RIM Mapping"/>
  </mapping>
  <kind value="resource"/>
  <abstract value="false"/>
  <type value="ManufacturedItemDefinition"/>
  <baseDefinition
                  value="http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition"/>
  <derivation value="constraint"/>
  <snapshot>
    <element id="ManufacturedItemDefinition">
      <path value="ManufacturedItemDefinition"/>
      <short
             value="The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product"/>
      <definition
                  value="The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ManufacturedItemDefinition"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <constraint>
        <key value="dom-2"/>
        <severity value="error"/>
        <human
               value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/>
        <expression value="contained.contained.empty()"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
      </constraint>
      <constraint>
        <key value="dom-3"/>
        <severity value="error"/>
        <human
               value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource"/>
        <expression
                    value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
      </constraint>
      <constraint>
        <key value="dom-4"/>
        <severity value="error"/>
        <human
               value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/>
        <expression
                    value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
      </constraint>
      <constraint>
        <key value="dom-5"/>
        <severity value="error"/>
        <human
               value="If a resource is contained in another resource, it SHALL NOT have a security label"/>
        <expression value="contained.meta.security.empty()"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
      </constraint>
      <constraint>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
          <valueBoolean value="true"/>
        </extension>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
          <valueMarkdown
                         value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/>
        </extension>
        <key value="dom-6"/>
        <severity value="warning"/>
        <human
               value="A resource should have narrative for robust management"/>
        <expression value="text.`div`.exists()"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="Entity, Role, or Act"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="administrative.medication"/>
      </mapping>
      <mapping>
        <identity value="idmp"/>
        <map value="Manufactured Item"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.id">
      <path value="ManufacturedItemDefinition.id"/>
      <short value="Logical id of this artifact"/>
      <definition
                  value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/>
      <comment
               value="Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.meta">
      <path value="ManufacturedItemDefinition.meta"/>
      <short value="Metadata about the resource"/>
      <definition
                  value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.meta"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Meta"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.implicitRules">
      <path value="ManufacturedItemDefinition.implicitRules"/>
      <short value="A set of rules under which this content was created"/>
      <definition
                  value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/>
      <comment
               value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.implicitRules"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="true"/>
      <isModifierReason
                        value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation"/>
      <isSummary value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.language">
      <path value="ManufacturedItemDefinition.language"/>
      <short value="Language of the resource content"/>
      <definition
                  value="The base language in which the resource is written."/>
      <comment
               value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies  to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.language"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="Language"/>
        </extension>
        <strength value="required"/>
        <description value="IETF language tag for a human language"/>
        <valueSet value="http://hl7.org/fhir/ValueSet/all-languages|5.0.0"/>
        <additional>
          <purpose value="starter"/>
          <valueSet value="http://hl7.org/fhir/ValueSet/languages"/>
        </additional>
      </binding>
    </element>
    <element id="ManufacturedItemDefinition.text">
      <path value="ManufacturedItemDefinition.text"/>
      <short value="Text summary of the resource, for human interpretation"/>
      <definition
                  value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it &quot;clinically safe&quot; for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/>
      <comment
               value="Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied).  This may be necessary for data from legacy systems where information is captured as a &quot;text blob&quot; or where text is additionally entered raw or narrated and encoded information is added later."/>
      <alias value="narrative"/>
      <alias value="html"/>
      <alias value="xhtml"/>
      <alias value="display"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.text"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Narrative"/>
      </type>
      <condition value="dom-6"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="Act.text?"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.contained">
      <path value="ManufacturedItemDefinition.contained"/>
      <short value="Contained, inline Resources"/>
      <definition
                  value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning."/>
      <comment
               value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels."/>
      <alias value="inline resources"/>
      <alias value="anonymous resources"/>
      <alias value="contained resources"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.contained"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Resource"/>
      </type>
      <condition value="dom-2"/>
      <condition value="dom-4"/>
      <condition value="dom-3"/>
      <condition value="dom-5"/>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.extension">
      <path value="ManufacturedItemDefinition.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.modifierExtension">
      <path value="ManufacturedItemDefinition.modifierExtension"/>
      <short value="Extensions that cannot be ignored"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="true"/>
      <isModifierReason
                        value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.identifier">
      <path value="ManufacturedItemDefinition.identifier"/>
      <short value="optional user designated identifier"/>
      <definition value="Unique identifier."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.identifier"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.class"/>
      </mapping>
      <mapping>
        <identity value="idmp"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.status">
      <path value="ManufacturedItemDefinition.status"/>
      <short value="draft | active | retired | unknown"/>
      <definition
                  value="The status of this item. Enables tracking the life-cycle of the content."/>
      <comment
               value="Allows filtering of manufactured items that are appropriate for use versus not."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.status"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="true"/>
      <isModifierReason
                        value="This is labeled as &quot;Is Modifier&quot; because applications should not use a retired {{title}} without due consideration"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="PublicationStatus"/>
        </extension>
        <strength value="required"/>
        <description value="The lifecycle status of an artifact."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/publication-status|5.0.0"/>
      </binding>
      <mapping>
        <identity value="idmp"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.name">
      <path value="ManufacturedItemDefinition.name"/>
      <short value="Product Non-proprietary Name"/>
      <definition
                  value="A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional. [Source: SME Defined]"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.name"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.class"/>
      </mapping>
      <mapping>
        <identity value="idmp"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.manufacturedDoseForm">
      <path value="ManufacturedItemDefinition.manufacturedDoseForm"/>
      <short
             value="Dose form as manufactured (before any necessary transformation)"/>
      <definition
                  value="Dose form as manufactured and before any transformation into the pharmaceutical product."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.manufacturedDoseForm"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology"/>
      </binding>
      <mapping>
        <identity value="idmp"/>
        <map value="Manufactured Item.Manufactured Dose Form"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.unitOfPresentation">
      <path value="ManufacturedItemDefinition.unitOfPresentation"/>
      <short
             value="The “real-world” units in which the quantity of the item is described"/>
      <definition
                  value="The “real-world” units in which the quantity of the manufactured item is described."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.unitOfPresentation"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="UnitOfPresentation"/>
        </extension>
        <strength value="example"/>
        <description
                     value="The presentation type in which an administrable medicinal product is given to a patient."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/unit-of-presentation"/>
      </binding>
      <mapping>
        <identity value="idmp"/>
        <map value="Manufactured Item.Unit of Presentation"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.manufacturer">
      <path value="ManufacturedItemDefinition.manufacturer"/>
      <short value="Manufacturer of the item, one of several possible"/>
      <definition value="Manufacturer of the item, one of several possible."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ManufacturedItemDefinition.manufacturer"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Reference"/>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
        <aggregation value="bundled"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="idmp"/>
        <map
             value="Manufactured Item.Manufacturer / Establishment (Organisation)"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.marketingStatus">
      <path value="ManufacturedItemDefinition.marketingStatus"/>
      <short
             value="Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated"/>
      <definition
                  value="Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ManufacturedItemDefinition.marketingStatus"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="MarketingStatus"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="idmp"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.ingredient">
      <path value="ManufacturedItemDefinition.ingredient"/>
      <short
             value="The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource"/>
      <definition
                  value="The ingredients of this manufactured item. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ManufacturedItemDefinition.ingredient"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="SNOMEDCTSubstanceCodes"/>
        </extension>
        <strength value="example"/>
        <description
                     value="This value set includes all substance codes from SNOMED CT - provided as an exemplar value set."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/substance-codes"/>
      </binding>
      <mapping>
        <identity value="idmp"/>
        <map
             value="Manufactured Item.Ingredient (see also FHIR Ingredient resource)"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property">
      <path value="ManufacturedItemDefinition.property"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="type.text"/>
        </discriminator>
        <description value="Slice based on value"/>
        <rules value="closed"/>
      </slicing>
      <short value="General characteristics of this item"/>
      <definition value="General characteristics of this item."/>
      <min value="2"/>
      <max value="*"/>
      <base>
        <path value="ManufacturedItemDefinition.property"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="idmp"/>
        <map value="Manufactured Item.Physical Characteristics"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property.id">
      <path value="ManufacturedItemDefinition.property.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property.extension">
      <path value="ManufacturedItemDefinition.property.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property.modifierExtension">
      <path value="ManufacturedItemDefinition.property.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property.type">
      <path value="ManufacturedItemDefinition.property.type"/>
      <short value="A code expressing the type of characteristic"/>
      <definition value="A code expressing the type of characteristic."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property.type"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="SNOMEDCTCharacteristicCodes"/>
        </extension>
        <strength value="example"/>
        <description
                     value="This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/product-characteristic-codes"/>
      </binding>
      <mapping>
        <identity value="idmp"/>
        <map value="Physical Characteristics, all attributes"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property.type.id">
      <path value="ManufacturedItemDefinition.property.type.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property.type.extension">
      <path value="ManufacturedItemDefinition.property.type.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property.type.coding">
      <path value="ManufacturedItemDefinition.property.type.coding"/>
      <short value="Code defined by a terminology system"/>
      <definition
                  value="A reference to a code defined by a terminology system."/>
      <comment
               value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
      <requirements
                    value="Allows for alternative encodings within a code system, and translations to other code systems."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="CodeableConcept.coding"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Coding"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.1-8, C*E.10-22"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="union(., ./translation)"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property.type.text">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="ManufacturedItemDefinition.property.type.text"/>
      <short value="Plain text representation of the concept"/>
      <definition
                  value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/>
      <comment
               value="Very often the text is the same as a displayName of one of the codings."/>
      <requirements
                    value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="CodeableConcept.text"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.9. But note many systems use C*E.2 for this"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="./originalText[mediaType/code=&quot;text/plain&quot;]/data"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property.value[x]">
      <path value="ManufacturedItemDefinition.property.value[x]"/>
      <short value="A value for the characteristic"/>
      <definition value="A value for the characteristic."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <type>
        <code value="Quantity"/>
      </type>
      <type>
        <code value="date"/>
      </type>
      <type>
        <code value="boolean"/>
      </type>
      <type>
        <code value="markdown"/>
      </type>
      <type>
        <code value="Attachment"/>
      </type>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/Binary"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="idmp"/>
        <map value="Physical Characteristics, attribute's value"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchSize">
      <path value="ManufacturedItemDefinition.property"/>
      <sliceName value="BatchSize"/>
      <short value="Batch Quantity"/>
      <definition
                  value="The amount of material in a specific batch size [Source: SME Defined]
Example: 1000 kg"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="idmp"/>
        <map value="Manufactured Item.Physical Characteristics"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchSize.id">
      <path value="ManufacturedItemDefinition.property.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchSize.extension">
      <path value="ManufacturedItemDefinition.property.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.property:BatchSize.modifierExtension">
      <path value="ManufacturedItemDefinition.property.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchSize.type">
      <path value="ManufacturedItemDefinition.property.type"/>
      <short value="A code expressing the type of characteristic"/>
      <definition value="A code expressing the type of characteristic."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property.type"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="SNOMEDCTCharacteristicCodes"/>
        </extension>
        <strength value="example"/>
        <description
                     value="This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/product-characteristic-codes"/>
      </binding>
      <mapping>
        <identity value="idmp"/>
        <map value="Physical Characteristics, all attributes"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchSize.type.id">
      <path value="ManufacturedItemDefinition.property.type.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.property:BatchSize.type.extension">
      <path value="ManufacturedItemDefinition.property.type.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchSize.type.coding">
      <path value="ManufacturedItemDefinition.property.type.coding"/>
      <short value="Code defined by a terminology system"/>
      <definition
                  value="A reference to a code defined by a terminology system."/>
      <comment
               value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
      <requirements
                    value="Allows for alternative encodings within a code system, and translations to other code systems."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="CodeableConcept.coding"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Coding"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.1-8, C*E.10-22"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="union(., ./translation)"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchSize.type.text">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="ManufacturedItemDefinition.property.type.text"/>
      <short value="Plain text representation of the concept"/>
      <definition
                  value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/>
      <comment
               value="Very often the text is the same as a displayName of one of the codings."/>
      <requirements
                    value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="CodeableConcept.text"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <patternString value="Batch Quantity"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.9. But note many systems use C*E.2 for this"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="./originalText[mediaType/code=&quot;text/plain&quot;]/data"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchSize.value[x]">
      <path value="ManufacturedItemDefinition.property.value[x]"/>
      <short value="A value for the characteristic"/>
      <definition value="A value for the characteristic."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Quantity"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure"/>
      </binding>
      <mapping>
        <identity value="idmp"/>
        <map value="Physical Characteristics, attribute's value"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchSize.value[x].id">
      <path value="ManufacturedItemDefinition.property.value[x].id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.property:BatchSize.value[x].extension">
      <path value="ManufacturedItemDefinition.property.value[x].extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.property:BatchSize.value[x].value">
      <path value="ManufacturedItemDefinition.property.value[x].value"/>
      <short value="Numerical value (with implicit precision)"/>
      <definition
                  value="The value of the measured amount. The value includes an implicit precision in the presentation of the value."/>
      <comment
               value="The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books)."/>
      <requirements
                    value="Precision is handled implicitly in almost all cases of measurement."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Quantity.value"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="decimal"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="SN.2  / CQ - N/A"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.property:BatchSize.value[x].comparator">
      <path value="ManufacturedItemDefinition.property.value[x].comparator"/>
      <short
             value="&lt; | &lt;= | &gt;= | &gt; | ad - how to understand the value"/>
      <definition
                  value="How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is &quot;&lt;&quot; , then the real value is &lt; stated value."/>
      <requirements
                    value="Need a framework for handling measures where the value is &lt;5ug/L or &gt;400mg/L due to the limitations of measuring methodology."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Quantity.comparator"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <meaningWhenMissing
                          value="If there is no comparator, then there is no modification of the value"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="This is labeled as &quot;Is Modifier&quot; because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="QuantityComparator"/>
        </extension>
        <strength value="required"/>
        <description
                     value="How the Quantity should be understood and represented."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="SN.1  / CQ.1"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="IVL properties"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.property:BatchSize.value[x].unit">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="ManufacturedItemDefinition.property.value[x].unit"/>
      <short value="Unit representation"/>
      <definition value="A human-readable form of the unit."/>
      <requirements
                    value="There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Quantity.unit"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="(see OBX.6 etc.) / CQ.2"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="PQ.unit"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.property:BatchSize.value[x].system">
      <path value="ManufacturedItemDefinition.property.value[x].system"/>
      <short value="System that defines coded unit form"/>
      <definition
                  value="The identification of the system that provides the coded form of the unit."/>
      <requirements
                    value="Need to know the system that defines the coded form of the unit."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Quantity.system"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <condition value="qty-3"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="(see OBX.6 etc.) / CQ.2"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="CO.codeSystem, PQ.translation.codeSystem"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.property:BatchSize.value[x].code">
      <path value="ManufacturedItemDefinition.property.value[x].code"/>
      <short value="Quantity UOM"/>
      <definition
                  value="A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI EVS - C25709]"/>
      <comment
               value="The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency.  The context of use may additionally require a code from a particular system."/>
      <requirements
                    value="Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Quantity.code"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <condition value="qty-3"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="(see OBX.6 etc.) / CQ.2"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="PQ.code, MO.currency, PQ.translation.code"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchUtil">
      <path value="ManufacturedItemDefinition.property"/>
      <sliceName value="BatchUtil"/>
      <short value="Batch Utilization"/>
      <definition
                  value="A categorization of the batch that identifies its usage. [Source: SME Defined]
Examples: commercial, development."/>
      <min value="1"/>
      <max value="*"/>
      <base>
        <path value="ManufacturedItemDefinition.property"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="idmp"/>
        <map value="Manufactured Item.Physical Characteristics"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchUtil.id">
      <path value="ManufacturedItemDefinition.property.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchUtil.extension">
      <path value="ManufacturedItemDefinition.property.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.property:BatchUtil.modifierExtension">
      <path value="ManufacturedItemDefinition.property.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchUtil.type">
      <path value="ManufacturedItemDefinition.property.type"/>
      <short value="A code expressing the type of characteristic"/>
      <definition value="A code expressing the type of characteristic."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property.type"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="SNOMEDCTCharacteristicCodes"/>
        </extension>
        <strength value="example"/>
        <description
                     value="This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/product-characteristic-codes"/>
      </binding>
      <mapping>
        <identity value="idmp"/>
        <map value="Physical Characteristics, all attributes"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchUtil.type.id">
      <path value="ManufacturedItemDefinition.property.type.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.property:BatchUtil.type.extension">
      <path value="ManufacturedItemDefinition.property.type.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchUtil.type.coding">
      <path value="ManufacturedItemDefinition.property.type.coding"/>
      <short value="Code defined by a terminology system"/>
      <definition
                  value="A reference to a code defined by a terminology system."/>
      <comment
               value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
      <requirements
                    value="Allows for alternative encodings within a code system, and translations to other code systems."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="CodeableConcept.coding"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Coding"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.1-8, C*E.10-22"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="union(., ./translation)"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchUtil.type.text">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="ManufacturedItemDefinition.property.type.text"/>
      <short value="Plain text representation of the concept"/>
      <definition
                  value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/>
      <comment
               value="Very often the text is the same as a displayName of one of the codings."/>
      <requirements
                    value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="CodeableConcept.text"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <patternString value="Batch Utilization"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.9. But note many systems use C*E.2 for this"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="./originalText[mediaType/code=&quot;text/plain&quot;]/data"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchUtil.value[x]">
      <path value="ManufacturedItemDefinition.property.value[x]"/>
      <short value="A value for the characteristic"/>
      <definition value="A value for the characteristic."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology"/>
      </binding>
      <mapping>
        <identity value="idmp"/>
        <map value="Physical Characteristics, attribute's value"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:AddInfo">
      <path value="ManufacturedItemDefinition.property"/>
      <sliceName value="AddInfo"/>
      <short value="Batch Formula Additional Information"/>
      <definition
                  value="A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying.
Implementation note: This is represented in  markdown.  For multiple comments utilize markdwon formating for separation of notes."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="idmp"/>
        <map value="Manufactured Item.Physical Characteristics"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:AddInfo.id">
      <path value="ManufacturedItemDefinition.property.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:AddInfo.extension">
      <path value="ManufacturedItemDefinition.property.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.property:AddInfo.modifierExtension">
      <path value="ManufacturedItemDefinition.property.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:AddInfo.type">
      <path value="ManufacturedItemDefinition.property.type"/>
      <short value="A code expressing the type of characteristic"/>
      <definition value="A code expressing the type of characteristic."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property.type"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="SNOMEDCTCharacteristicCodes"/>
        </extension>
        <strength value="example"/>
        <description
                     value="This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/product-characteristic-codes"/>
      </binding>
      <mapping>
        <identity value="idmp"/>
        <map value="Physical Characteristics, all attributes"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:AddInfo.type.id">
      <path value="ManufacturedItemDefinition.property.type.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:AddInfo.type.extension">
      <path value="ManufacturedItemDefinition.property.type.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:AddInfo.type.coding">
      <path value="ManufacturedItemDefinition.property.type.coding"/>
      <short value="Code defined by a terminology system"/>
      <definition
                  value="A reference to a code defined by a terminology system."/>
      <comment
               value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
      <requirements
                    value="Allows for alternative encodings within a code system, and translations to other code systems."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="CodeableConcept.coding"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Coding"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.1-8, C*E.10-22"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="union(., ./translation)"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:AddInfo.type.text">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="ManufacturedItemDefinition.property.type.text"/>
      <short value="Plain text representation of the concept"/>
      <definition
                  value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/>
      <comment
               value="Very often the text is the same as a displayName of one of the codings."/>
      <requirements
                    value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="CodeableConcept.text"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <patternString value="Product Part Additional Information"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.9. But note many systems use C*E.2 for this"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="./originalText[mediaType/code=&quot;text/plain&quot;]/data"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.property:AddInfo.value[x]">
      <path value="ManufacturedItemDefinition.property.value[x]"/>
      <short value="A value for the characteristic"/>
      <definition value="A value for the characteristic."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="markdown"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="idmp"/>
        <map value="Physical Characteristics, attribute's value"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component">
      <path value="ManufacturedItemDefinition.component"/>
      <short
             value="Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup"/>
      <definition
                  value="Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup."/>
      <min value="1"/>
      <max value="*"/>
      <base>
        <path value="ManufacturedItemDefinition.component"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="idmp"/>
        <map value="Manufactured Item.Physical Characteristics"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.id">
      <path value="ManufacturedItemDefinition.component.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.extension">
      <path value="ManufacturedItemDefinition.component.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.modifierExtension">
      <path value="ManufacturedItemDefinition.component.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.type">
      <path value="ManufacturedItemDefinition.component.type"/>
      <short value="Product Part Type"/>
      <definition
                  value="Identifies the kind of element, based on the design the applicant develops to achieve the desired drug product and overall release profile. [Source: SME Defined]
Example: Layer, Bead, Minitablet, Capsule Shell, Coating"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.component.type"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type"/>
      </binding>
      <mapping>
        <identity value="idmp"/>
        <map value="Physical Characteristics, all attributes"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.function">
      <path value="ManufacturedItemDefinition.component.function"/>
      <short
             value="The function of this component within the item e.g. delivers active ingredient, masks taste"/>
      <definition
                  value="The function of this component within the item e.g. delivers active ingredient, masks taste."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ManufacturedItemDefinition.component.function"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.amount">
      <path value="ManufacturedItemDefinition.component.amount"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="code"/>
        </discriminator>
        <description value="Slice based on value of unit"/>
        <rules value="closed"/>
      </slicing>
      <short
             value="The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)"/>
      <definition
                  value="The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)."/>
      <min value="2"/>
      <max value="2"/>
      <base>
        <path value="ManufacturedItemDefinition.component.amount"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Quantity"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:perBatch">
      <path value="ManufacturedItemDefinition.component.amount"/>
      <sliceName value="perBatch"/>
      <short value="Component Quantity Per Batch"/>
      <definition
                  value="Specifies the amount of the component per batch size of the drug product. [Source: SME Defined]"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.component.amount"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Quantity"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:perBatch.id">
      <path value="ManufacturedItemDefinition.component.amount.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.amount:perBatch.extension">
      <path value="ManufacturedItemDefinition.component.amount.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:perBatch.value">
      <path value="ManufacturedItemDefinition.component.amount.value"/>
      <short value="Numerical value (with implicit precision)"/>
      <definition
                  value="The value of the measured amount. The value includes an implicit precision in the presentation of the value."/>
      <comment
               value="The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books)."/>
      <requirements
                    value="Precision is handled implicitly in almost all cases of measurement."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Quantity.value"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="decimal"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="SN.2  / CQ - N/A"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.amount:perBatch.comparator">
      <path value="ManufacturedItemDefinition.component.amount.comparator"/>
      <short
             value="&lt; | &lt;= | &gt;= | &gt; | ad - how to understand the value"/>
      <definition
                  value="How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is &quot;&lt;&quot; , then the real value is &lt; stated value."/>
      <requirements
                    value="Need a framework for handling measures where the value is &lt;5ug/L or &gt;400mg/L due to the limitations of measuring methodology."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Quantity.comparator"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <meaningWhenMissing
                          value="If there is no comparator, then there is no modification of the value"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="This is labeled as &quot;Is Modifier&quot; because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="QuantityComparator"/>
        </extension>
        <strength value="required"/>
        <description
                     value="How the Quantity should be understood and represented."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="SN.1  / CQ.1"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="IVL properties"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:perBatch.unit">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="ManufacturedItemDefinition.component.amount.unit"/>
      <short value="Unit representation"/>
      <definition value="A human-readable form of the unit."/>
      <requirements
                    value="There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Quantity.unit"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="(see OBX.6 etc.) / CQ.2"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="PQ.unit"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.amount:perBatch.system">
      <path value="ManufacturedItemDefinition.component.amount.system"/>
      <short value="System that defines coded unit form"/>
      <definition
                  value="The identification of the system that provides the coded form of the unit."/>
      <requirements
                    value="Need to know the system that defines the coded form of the unit."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Quantity.system"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <condition value="qty-3"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="(see OBX.6 etc.) / CQ.2"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="CO.codeSystem, PQ.translation.codeSystem"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:perBatch.code">
      <path value="ManufacturedItemDefinition.component.amount.code"/>
      <short value="Coded form of the unit"/>
      <definition
                  value="A computer processable form of the unit in some unit representation system."/>
      <comment
               value="The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency.  The context of use may additionally require a code from a particular system."/>
      <requirements
                    value="Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Quantity.code"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <condition value="qty-3"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="(see OBX.6 etc.) / CQ.2"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="PQ.code, MO.currency, PQ.translation.code"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:percent">
      <path value="ManufacturedItemDefinition.component.amount"/>
      <sliceName value="percent"/>
      <short
             value="The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)"/>
      <definition
                  value="The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.component.amount"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Quantity"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:percent.id">
      <path value="ManufacturedItemDefinition.component.amount.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.amount:percent.extension">
      <path value="ManufacturedItemDefinition.component.amount.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:percent.value">
      <path value="ManufacturedItemDefinition.component.amount.value"/>
      <short value="Numerical value (with implicit precision)"/>
      <definition
                  value="The value of the measured amount. The value includes an implicit precision in the presentation of the value."/>
      <comment
               value="The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books)."/>
      <requirements
                    value="Precision is handled implicitly in almost all cases of measurement."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Quantity.value"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="decimal"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="SN.2  / CQ - N/A"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.amount:percent.comparator">
      <path value="ManufacturedItemDefinition.component.amount.comparator"/>
      <short
             value="&lt; | &lt;= | &gt;= | &gt; | ad - how to understand the value"/>
      <definition
                  value="How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is &quot;&lt;&quot; , then the real value is &lt; stated value."/>
      <requirements
                    value="Need a framework for handling measures where the value is &lt;5ug/L or &gt;400mg/L due to the limitations of measuring methodology."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Quantity.comparator"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <meaningWhenMissing
                          value="If there is no comparator, then there is no modification of the value"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="This is labeled as &quot;Is Modifier&quot; because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="QuantityComparator"/>
        </extension>
        <strength value="required"/>
        <description
                     value="How the Quantity should be understood and represented."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="SN.1  / CQ.1"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="IVL properties"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:percent.unit">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="ManufacturedItemDefinition.component.amount.unit"/>
      <short value="Unit representation"/>
      <definition value="A human-readable form of the unit."/>
      <requirements
                    value="There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Quantity.unit"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="(see OBX.6 etc.) / CQ.2"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="PQ.unit"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:percent.system">
      <path value="ManufacturedItemDefinition.component.amount.system"/>
      <short value="System that defines coded unit form"/>
      <definition
                  value="The identification of the system that provides the coded form of the unit."/>
      <requirements
                    value="Need to know the system that defines the coded form of the unit."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Quantity.system"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <condition value="qty-3"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="(see OBX.6 etc.) / CQ.2"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="CO.codeSystem, PQ.translation.codeSystem"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:percent.code">
      <path value="ManufacturedItemDefinition.component.amount.code"/>
      <short value="Coded form of the unit"/>
      <definition
                  value="A computer processable form of the unit in some unit representation system."/>
      <comment
               value="The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency.  The context of use may additionally require a code from a particular system."/>
      <requirements
                    value="Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Quantity.code"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <condition value="qty-3"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="(see OBX.6 etc.) / CQ.2"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="PQ.code, MO.currency, PQ.translation.code"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.constituent">
      <path value="ManufacturedItemDefinition.component.constituent"/>
      <short
             value="A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)"/>
      <definition
                  value="A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)."/>
      <min value="1"/>
      <max value="*"/>
      <base>
        <path value="ManufacturedItemDefinition.component.constituent"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.constituent.id">
      <path value="ManufacturedItemDefinition.component.constituent.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.constituent.extension">
      <path
            value="ManufacturedItemDefinition.component.constituent.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.extension:additional-info">
      <path
            value="ManufacturedItemDefinition.component.constituent.extension"/>
      <sliceName value="additional-info"/>
      <short value="Drug Product Constituent Additional Information"/>
      <definition
                  value="A placeholder for providing any comments relevant to the constituent [Source: SME Defined]
Examples: Water for wet granulation - removed during process; adjusted for loss on drying, etc.* property["/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.extension:formulaIngredient">
      <path
            value="ManufacturedItemDefinition.component.constituent.extension"/>
      <sliceName value="formulaIngredient"/>
      <short value="Product Batch Ingredient Extension"/>
      <definition
                  value="Extension for measurement properties for ingredients in the batch formla."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.extension:StrengthTextual">
      <path
            value="ManufacturedItemDefinition.component.constituent.extension"/>
      <sliceName value="StrengthTextual"/>
      <short value="Product Batch Strength Textual Extension"/>
      <definition
                  value="Extension for strenght as a string for ingredients in the batch formla."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.modifierExtension">
      <path
            value="ManufacturedItemDefinition.component.constituent.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.constituent.amount">
      <path value="ManufacturedItemDefinition.component.constituent.amount"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="code"/>
        </discriminator>
        <description value="Slice based on value of unit"/>
        <rules value="closed"/>
      </slicing>
      <short
             value="The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)"/>
      <definition
                  value="The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)."/>
      <min value="2"/>
      <max value="2"/>
      <base>
        <path
              value="ManufacturedItemDefinition.component.constituent.amount"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Quantity"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:perBatch">
      <path value="ManufacturedItemDefinition.component.constituent.amount"/>
      <sliceName value="perBatch"/>
      <short value="Component Quantity Per Batch"/>
      <definition
                  value="Specifies the amount of the component per batch size of the drug product. [Source: SME Defined]"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path
              value="ManufacturedItemDefinition.component.constituent.amount"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Quantity"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:perBatch.id">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:perBatch.extension">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:perBatch.value">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.value"/>
      <short value="Numerical value (with implicit precision)"/>
      <definition
                  value="The value of the measured amount. The value includes an implicit precision in the presentation of the value."/>
      <comment
               value="The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books)."/>
      <requirements
                    value="Precision is handled implicitly in almost all cases of measurement."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Quantity.value"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="decimal"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="SN.2  / CQ - N/A"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:perBatch.comparator">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.comparator"/>
      <short
             value="&lt; | &lt;= | &gt;= | &gt; | ad - how to understand the value"/>
      <definition
                  value="How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is &quot;&lt;&quot; , then the real value is &lt; stated value."/>
      <requirements
                    value="Need a framework for handling measures where the value is &lt;5ug/L or &gt;400mg/L due to the limitations of measuring methodology."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Quantity.comparator"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <meaningWhenMissing
                          value="If there is no comparator, then there is no modification of the value"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="This is labeled as &quot;Is Modifier&quot; because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="QuantityComparator"/>
        </extension>
        <strength value="required"/>
        <description
                     value="How the Quantity should be understood and represented."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="SN.1  / CQ.1"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="IVL properties"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:perBatch.unit">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.unit"/>
      <short value="Unit representation"/>
      <definition value="A human-readable form of the unit."/>
      <requirements
                    value="There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Quantity.unit"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="(see OBX.6 etc.) / CQ.2"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="PQ.unit"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:perBatch.system">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.system"/>
      <short value="System that defines coded unit form"/>
      <definition
                  value="The identification of the system that provides the coded form of the unit."/>
      <requirements
                    value="Need to know the system that defines the coded form of the unit."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Quantity.system"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <condition value="qty-3"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="(see OBX.6 etc.) / CQ.2"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="CO.codeSystem, PQ.translation.codeSystem"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:perBatch.code">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.code"/>
      <short value="Coded form of the unit"/>
      <definition
                  value="A computer processable form of the unit in some unit representation system."/>
      <comment
               value="The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency.  The context of use may additionally require a code from a particular system."/>
      <requirements
                    value="Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Quantity.code"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <condition value="qty-3"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="(see OBX.6 etc.) / CQ.2"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="PQ.code, MO.currency, PQ.translation.code"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:percent">
      <path value="ManufacturedItemDefinition.component.constituent.amount"/>
      <sliceName value="percent"/>
      <short value="Quantity Percent"/>
      <definition
                  value="Quantity expressed as Volume To Volume: The percentage of the component in the batch [Source: SME Defined]
Quantity UOM: A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI E - C25709]"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path
              value="ManufacturedItemDefinition.component.constituent.amount"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Quantity"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:percent.id">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:percent.extension">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:percent.value">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.value"/>
      <short value="Numerical value (with implicit precision)"/>
      <definition
                  value="The value of the measured amount. The value includes an implicit precision in the presentation of the value."/>
      <comment
               value="The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books)."/>
      <requirements
                    value="Precision is handled implicitly in almost all cases of measurement."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Quantity.value"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="decimal"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="SN.2  / CQ - N/A"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:percent.comparator">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.comparator"/>
      <short
             value="&lt; | &lt;= | &gt;= | &gt; | ad - how to understand the value"/>
      <definition
                  value="How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is &quot;&lt;&quot; , then the real value is &lt; stated value."/>
      <requirements
                    value="Need a framework for handling measures where the value is &lt;5ug/L or &gt;400mg/L due to the limitations of measuring methodology."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Quantity.comparator"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <meaningWhenMissing
                          value="If there is no comparator, then there is no modification of the value"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="This is labeled as &quot;Is Modifier&quot; because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="QuantityComparator"/>
        </extension>
        <strength value="required"/>
        <description
                     value="How the Quantity should be understood and represented."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="SN.1  / CQ.1"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="IVL properties"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:percent.unit">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.unit"/>
      <short value="Unit representation"/>
      <definition value="A human-readable form of the unit."/>
      <requirements
                    value="There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Quantity.unit"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="(see OBX.6 etc.) / CQ.2"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="PQ.unit"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:percent.system">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.system"/>
      <short value="System that defines coded unit form"/>
      <definition
                  value="The identification of the system that provides the coded form of the unit."/>
      <requirements
                    value="Need to know the system that defines the coded form of the unit."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Quantity.system"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <condition value="qty-3"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="(see OBX.6 etc.) / CQ.2"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="CO.codeSystem, PQ.translation.codeSystem"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:percent.code">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.code"/>
      <short value="Coded form of the unit"/>
      <definition
                  value="A computer processable form of the unit in some unit representation system."/>
      <comment
               value="The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency.  The context of use may additionally require a code from a particular system."/>
      <requirements
                    value="Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Quantity.code"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <condition value="qty-3"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="(see OBX.6 etc.) / CQ.2"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="PQ.code, MO.currency, PQ.translation.code"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.constituent.location">
      <path
            value="ManufacturedItemDefinition.component.constituent.location"/>
      <short value="Product Part Ingredient Physical Location"/>
      <definition
                  value="Identifies where the ingredient physically resides within the product part. [Source: SME Defined]
Examples: Intragranular, Extra granular, Blend"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path
              value="ManufacturedItemDefinition.component.constituent.location"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location"/>
      </binding>
    </element>
    <element id="ManufacturedItemDefinition.component.constituent.function">
      <path
            value="ManufacturedItemDefinition.component.constituent.function"/>
      <short
             value="The function of this constituent within the component e.g. binder"/>
      <definition
                  value="The function of this constituent within the component e.g. binder."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path
              value="ManufacturedItemDefinition.component.constituent.function"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.hasIngredient">
      <path
            value="ManufacturedItemDefinition.component.constituent.hasIngredient"/>
      <short value="Reference to a resource or a concept"/>
      <definition
                  value="A reference to a resource (by instance), or instead, a reference to a concept defined in a terminology or ontology (by class)."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path
              value="ManufacturedItemDefinition.component.constituent.hasIngredient"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableReference"/>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
        <aggregation value="bundled"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.property">
      <path value="ManufacturedItemDefinition.component.property"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="type.text"/>
        </discriminator>
        <description value="Slice based on value"/>
        <rules value="closed"/>
      </slicing>
      <short value="General characteristics of this component"/>
      <definition value="General characteristics of this component."/>
      <min value="1"/>
      <max value="*"/>
      <base>
        <path value="ManufacturedItemDefinition.component.property"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.property.id">
      <path value="ManufacturedItemDefinition.component.property.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.property.extension">
      <path value="ManufacturedItemDefinition.component.property.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property.modifierExtension">
      <path
            value="ManufacturedItemDefinition.component.property.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.property.type">
      <path value="ManufacturedItemDefinition.component.property.type"/>
      <short value="A code expressing the type of characteristic"/>
      <definition value="A code expressing the type of characteristic."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property.type"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="SNOMEDCTCharacteristicCodes"/>
        </extension>
        <strength value="example"/>
        <description
                     value="This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/product-characteristic-codes"/>
      </binding>
      <mapping>
        <identity value="idmp"/>
        <map value="Physical Characteristics, all attributes"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.property.type.id">
      <path value="ManufacturedItemDefinition.component.property.type.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property.type.extension">
      <path
            value="ManufacturedItemDefinition.component.property.type.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.property.type.coding">
      <path
            value="ManufacturedItemDefinition.component.property.type.coding"/>
      <short value="Code defined by a terminology system"/>
      <definition
                  value="A reference to a code defined by a terminology system."/>
      <comment
               value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
      <requirements
                    value="Allows for alternative encodings within a code system, and translations to other code systems."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="CodeableConcept.coding"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Coding"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.1-8, C*E.10-22"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="union(., ./translation)"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.property.type.text">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="ManufacturedItemDefinition.component.property.type.text"/>
      <short value="Plain text representation of the concept"/>
      <definition
                  value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/>
      <comment
               value="Very often the text is the same as a displayName of one of the codings."/>
      <requirements
                    value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="CodeableConcept.text"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.9. But note many systems use C*E.2 for this"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="./originalText[mediaType/code=&quot;text/plain&quot;]/data"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.property.value[x]">
      <path value="ManufacturedItemDefinition.component.property.value[x]"/>
      <short value="A value for the characteristic"/>
      <definition value="A value for the characteristic."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <type>
        <code value="Quantity"/>
      </type>
      <type>
        <code value="date"/>
      </type>
      <type>
        <code value="boolean"/>
      </type>
      <type>
        <code value="markdown"/>
      </type>
      <type>
        <code value="Attachment"/>
      </type>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/Binary"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="idmp"/>
        <map value="Physical Characteristics, attribute's value"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.property:PPiD">
      <path value="ManufacturedItemDefinition.component.property"/>
      <sliceName value="PPiD"/>
      <short value="Product Part Identifier"/>
      <definition
                  value="A submitter designated identifier that uniquely identifies the part within the drug product. [Source: SME Defined]
Examples: 1, A1, Red bead, Blue minitablet"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.component.property"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.property:PPiD.id">
      <path value="ManufacturedItemDefinition.component.property.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:PPiD.extension">
      <path value="ManufacturedItemDefinition.component.property.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:PPiD.modifierExtension">
      <path
            value="ManufacturedItemDefinition.component.property.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.property:PPiD.type">
      <path value="ManufacturedItemDefinition.component.property.type"/>
      <short value="A code expressing the type of characteristic"/>
      <definition value="A code expressing the type of characteristic."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property.type"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="SNOMEDCTCharacteristicCodes"/>
        </extension>
        <strength value="example"/>
        <description
                     value="This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/product-characteristic-codes"/>
      </binding>
      <mapping>
        <identity value="idmp"/>
        <map value="Physical Characteristics, all attributes"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.property:PPiD.type.id">
      <path value="ManufacturedItemDefinition.component.property.type.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:PPiD.type.extension">
      <path
            value="ManufacturedItemDefinition.component.property.type.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:PPiD.type.coding">
      <path
            value="ManufacturedItemDefinition.component.property.type.coding"/>
      <short value="Code defined by a terminology system"/>
      <definition
                  value="A reference to a code defined by a terminology system."/>
      <comment
               value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
      <requirements
                    value="Allows for alternative encodings within a code system, and translations to other code systems."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="CodeableConcept.coding"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Coding"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.1-8, C*E.10-22"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="union(., ./translation)"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:PPiD.type.text">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="ManufacturedItemDefinition.component.property.type.text"/>
      <short value="Plain text representation of the concept"/>
      <definition
                  value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/>
      <comment
               value="Very often the text is the same as a displayName of one of the codings."/>
      <requirements
                    value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="CodeableConcept.text"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <patternString value="Product Part Identifier"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.9. But note many systems use C*E.2 for this"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="./originalText[mediaType/code=&quot;text/plain&quot;]/data"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:PPiD.value[x]">
      <path value="ManufacturedItemDefinition.component.property.value[x]"/>
      <short value="Concept - reference to a terminology or just  text"/>
      <definition
                  value="A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text."/>
      <comment
               value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a,CD"/>
      </mapping>
      <mapping>
        <identity value="v2"/>
        <map value="CE/CNE/CWE"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.property:PPiDref">
      <path value="ManufacturedItemDefinition.component.property"/>
      <sliceName value="PPiDref"/>
      <short value="Product Part Identifier Reference"/>
      <definition
                  value="Identifies the parent or outer-level product part. [Source: SME Defined]
Example: A bead (Product Part Identifier = “B1”) has a seal coating (Product Part Identifier = “SCoat”) and is contained in a Hard HPMC capsule shell (Product Part Identifier “Cap Shell”). For the seal coating, Product Part Identifier Reference = “B1”, because the seal coat is applied to the bead."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.component.property"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.property:PPiDref.id">
      <path value="ManufacturedItemDefinition.component.property.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:PPiDref.extension">
      <path value="ManufacturedItemDefinition.component.property.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:PPiDref.modifierExtension">
      <path
            value="ManufacturedItemDefinition.component.property.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.property:PPiDref.type">
      <path value="ManufacturedItemDefinition.component.property.type"/>
      <short value="A code expressing the type of characteristic"/>
      <definition value="A code expressing the type of characteristic."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property.type"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="SNOMEDCTCharacteristicCodes"/>
        </extension>
        <strength value="example"/>
        <description
                     value="This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/product-characteristic-codes"/>
      </binding>
      <mapping>
        <identity value="idmp"/>
        <map value="Physical Characteristics, all attributes"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:PPiDref.type.id">
      <path value="ManufacturedItemDefinition.component.property.type.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:PPiDref.type.extension">
      <path
            value="ManufacturedItemDefinition.component.property.type.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:PPiDref.type.coding">
      <path
            value="ManufacturedItemDefinition.component.property.type.coding"/>
      <short value="Code defined by a terminology system"/>
      <definition
                  value="A reference to a code defined by a terminology system."/>
      <comment
               value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
      <requirements
                    value="Allows for alternative encodings within a code system, and translations to other code systems."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="CodeableConcept.coding"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Coding"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.1-8, C*E.10-22"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="union(., ./translation)"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:PPiDref.type.text">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="ManufacturedItemDefinition.component.property.type.text"/>
      <short value="Plain text representation of the concept"/>
      <definition
                  value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/>
      <comment
               value="Very often the text is the same as a displayName of one of the codings."/>
      <requirements
                    value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="CodeableConcept.text"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <patternString value="Product Part Identifier Reference"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.9. But note many systems use C*E.2 for this"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="./originalText[mediaType/code=&quot;text/plain&quot;]/data"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:PPiDref.value[x]">
      <path value="ManufacturedItemDefinition.component.property.value[x]"/>
      <short value="Concept - reference to a terminology or just  text"/>
      <definition
                  value="A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text."/>
      <comment
               value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a,CD"/>
      </mapping>
      <mapping>
        <identity value="v2"/>
        <map value="CE/CNE/CWE"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.property:AddInfo">
      <path value="ManufacturedItemDefinition.component.property"/>
      <sliceName value="AddInfo"/>
      <short value="Product Part Additional Information"/>
      <definition
                  value="A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying.
Implementation note: This is represented in  markdown.  For multiple comments utilize markdwon formating for separation of notes."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.component.property"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.property:AddInfo.id">
      <path value="ManufacturedItemDefinition.component.property.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:AddInfo.extension">
      <path value="ManufacturedItemDefinition.component.property.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:AddInfo.modifierExtension">
      <path
            value="ManufacturedItemDefinition.component.property.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.property:AddInfo.type">
      <path value="ManufacturedItemDefinition.component.property.type"/>
      <short value="A code expressing the type of characteristic"/>
      <definition value="A code expressing the type of characteristic."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property.type"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="SNOMEDCTCharacteristicCodes"/>
        </extension>
        <strength value="example"/>
        <description
                     value="This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/product-characteristic-codes"/>
      </binding>
      <mapping>
        <identity value="idmp"/>
        <map value="Physical Characteristics, all attributes"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:AddInfo.type.id">
      <path value="ManufacturedItemDefinition.component.property.type.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:AddInfo.type.extension">
      <path
            value="ManufacturedItemDefinition.component.property.type.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:AddInfo.type.coding">
      <path
            value="ManufacturedItemDefinition.component.property.type.coding"/>
      <short value="Code defined by a terminology system"/>
      <definition
                  value="A reference to a code defined by a terminology system."/>
      <comment
               value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
      <requirements
                    value="Allows for alternative encodings within a code system, and translations to other code systems."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="CodeableConcept.coding"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Coding"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.1-8, C*E.10-22"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="union(., ./translation)"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:AddInfo.type.text">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="ManufacturedItemDefinition.component.property.type.text"/>
      <short value="Plain text representation of the concept"/>
      <definition
                  value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/>
      <comment
               value="Very often the text is the same as a displayName of one of the codings."/>
      <requirements
                    value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="CodeableConcept.text"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <patternString value="Product Part Additional Information"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.9. But note many systems use C*E.2 for this"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="./originalText[mediaType/code=&quot;text/plain&quot;]/data"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
      </mapping>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:AddInfo.value[x]">
      <path value="ManufacturedItemDefinition.component.property.value[x]"/>
      <short value="A value for the characteristic"/>
      <definition value="A value for the characteristic."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ManufacturedItemDefinition.property.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="markdown"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="idmp"/>
        <map value="Physical Characteristics, attribute's value"/>
      </mapping>
    </element>
    <element id="ManufacturedItemDefinition.component.component">
      <path value="ManufacturedItemDefinition.component.component"/>
      <short
             value="A component that this component contains or is made from"/>
      <definition
                  value="A component that this component contains or is made from."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ManufacturedItemDefinition.component.component"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <contentReference
                        value="http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition#ManufacturedItemDefinition.component"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
  </snapshot>
  <differential>
    <element id="ManufacturedItemDefinition.identifier">
      <path value="ManufacturedItemDefinition.identifier"/>
      <short value="optional user designated identifier"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.status">
      <path value="ManufacturedItemDefinition.status"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.name">
      <path value="ManufacturedItemDefinition.name"/>
      <short value="Product Non-proprietary Name"/>
      <definition
                  value="A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional. [Source: SME Defined]"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.manufacturedDoseForm">
      <path value="ManufacturedItemDefinition.manufacturedDoseForm"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology"/>
      </binding>
    </element>
    <element id="ManufacturedItemDefinition.manufacturer">
      <path value="ManufacturedItemDefinition.manufacturer"/>
      <type>
        <code value="Reference"/>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
        <aggregation value="bundled"/>
      </type>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.property">
      <path value="ManufacturedItemDefinition.property"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="type.text"/>
        </discriminator>
        <description value="Slice based on value"/>
        <rules value="closed"/>
      </slicing>
      <min value="2"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.property.type">
      <path value="ManufacturedItemDefinition.property.type"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.property.type.text">
      <path value="ManufacturedItemDefinition.property.type.text"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchSize">
      <path value="ManufacturedItemDefinition.property"/>
      <sliceName value="BatchSize"/>
      <short value="Batch Quantity"/>
      <definition
                  value="The amount of material in a specific batch size [Source: SME Defined]
Example: 1000 kg"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchSize.type.text">
      <path value="ManufacturedItemDefinition.property.type.text"/>
      <patternString value="Batch Quantity"/>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchSize.value[x]">
      <path value="ManufacturedItemDefinition.property.value[x]"/>
      <min value="1"/>
      <type>
        <code value="Quantity"/>
      </type>
      <mustSupport value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure"/>
      </binding>
    </element>
    <element
             id="ManufacturedItemDefinition.property:BatchSize.value[x].value">
      <path value="ManufacturedItemDefinition.property.value[x].value"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element
             id="ManufacturedItemDefinition.property:BatchSize.value[x].code">
      <path value="ManufacturedItemDefinition.property.value[x].code"/>
      <short value="Quantity UOM"/>
      <definition
                  value="A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI EVS - C25709]"/>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchUtil">
      <path value="ManufacturedItemDefinition.property"/>
      <sliceName value="BatchUtil"/>
      <short value="Batch Utilization"/>
      <definition
                  value="A categorization of the batch that identifies its usage. [Source: SME Defined]
Examples: commercial, development."/>
      <min value="1"/>
      <max value="*"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchUtil.type.text">
      <path value="ManufacturedItemDefinition.property.type.text"/>
      <patternString value="Batch Utilization"/>
    </element>
    <element id="ManufacturedItemDefinition.property:BatchUtil.value[x]">
      <path value="ManufacturedItemDefinition.property.value[x]"/>
      <min value="1"/>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <mustSupport value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology"/>
      </binding>
    </element>
    <element id="ManufacturedItemDefinition.property:AddInfo">
      <path value="ManufacturedItemDefinition.property"/>
      <sliceName value="AddInfo"/>
      <short value="Batch Formula Additional Information"/>
      <definition
                  value="A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying.
Implementation note: This is represented in  markdown.  For multiple comments utilize markdwon formating for separation of notes."/>
      <min value="0"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.property:AddInfo.type.text">
      <path value="ManufacturedItemDefinition.property.type.text"/>
      <patternString value="Product Part Additional Information"/>
    </element>
    <element id="ManufacturedItemDefinition.property:AddInfo.value[x]">
      <path value="ManufacturedItemDefinition.property.value[x]"/>
      <min value="1"/>
      <type>
        <code value="markdown"/>
      </type>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component">
      <path value="ManufacturedItemDefinition.component"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.type">
      <path value="ManufacturedItemDefinition.component.type"/>
      <short value="Product Part Type"/>
      <definition
                  value="Identifies the kind of element, based on the design the applicant develops to achieve the desired drug product and overall release profile. [Source: SME Defined]
Example: Layer, Bead, Minitablet, Capsule Shell, Coating"/>
      <mustSupport value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type"/>
      </binding>
    </element>
    <element id="ManufacturedItemDefinition.component.amount">
      <path value="ManufacturedItemDefinition.component.amount"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="code"/>
        </discriminator>
        <description value="Slice based on value of unit"/>
        <rules value="closed"/>
      </slicing>
      <min value="2"/>
      <max value="2"/>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:perBatch">
      <path value="ManufacturedItemDefinition.component.amount"/>
      <sliceName value="perBatch"/>
      <short value="Component Quantity Per Batch"/>
      <definition
                  value="Specifies the amount of the component per batch size of the drug product. [Source: SME Defined]"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:perBatch.value">
      <path value="ManufacturedItemDefinition.component.amount.value"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:perBatch.unit">
      <path value="ManufacturedItemDefinition.component.amount.unit"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:perBatch.code">
      <path value="ManufacturedItemDefinition.component.amount.code"/>
      <min value="1"/>
      <mustSupport value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units"/>
      </binding>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:percent">
      <path value="ManufacturedItemDefinition.component.amount"/>
      <sliceName value="percent"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:percent.value">
      <path value="ManufacturedItemDefinition.component.amount.value"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:percent.unit">
      <path value="ManufacturedItemDefinition.component.amount.unit"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.amount:percent.code">
      <path value="ManufacturedItemDefinition.component.amount.code"/>
      <min value="1"/>
      <mustSupport value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units"/>
      </binding>
    </element>
    <element id="ManufacturedItemDefinition.component.constituent">
      <path value="ManufacturedItemDefinition.component.constituent"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.constituent.extension">
      <path
            value="ManufacturedItemDefinition.component.constituent.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.extension:additional-info">
      <path
            value="ManufacturedItemDefinition.component.constituent.extension"/>
      <sliceName value="additional-info"/>
      <short value="Drug Product Constituent Additional Information"/>
      <definition
                  value="A placeholder for providing any comments relevant to the constituent [Source: SME Defined]
Examples: Water for wet granulation - removed during process; adjusted for loss on drying, etc.* property["/>
      <min value="0"/>
      <max value="1"/>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension"/>
      </type>
      <mustSupport value="true"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.extension:formulaIngredient">
      <path
            value="ManufacturedItemDefinition.component.constituent.extension"/>
      <sliceName value="formulaIngredient"/>
      <min value="0"/>
      <max value="1"/>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension"/>
      </type>
      <mustSupport value="true"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.extension:StrengthTextual">
      <path
            value="ManufacturedItemDefinition.component.constituent.extension"/>
      <sliceName value="StrengthTextual"/>
      <min value="0"/>
      <max value="1"/>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension"/>
      </type>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.constituent.amount">
      <path value="ManufacturedItemDefinition.component.constituent.amount"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="code"/>
        </discriminator>
        <description value="Slice based on value of unit"/>
        <rules value="closed"/>
      </slicing>
      <min value="2"/>
      <max value="2"/>
      <mustSupport value="true"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:perBatch">
      <path value="ManufacturedItemDefinition.component.constituent.amount"/>
      <sliceName value="perBatch"/>
      <short value="Component Quantity Per Batch"/>
      <definition
                  value="Specifies the amount of the component per batch size of the drug product. [Source: SME Defined]"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:perBatch.value">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.value"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:perBatch.unit">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.unit"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:perBatch.code">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.code"/>
      <min value="1"/>
      <mustSupport value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units"/>
      </binding>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:percent">
      <path value="ManufacturedItemDefinition.component.constituent.amount"/>
      <sliceName value="percent"/>
      <short value="Quantity Percent"/>
      <definition
                  value="Quantity expressed as Volume To Volume: The percentage of the component in the batch [Source: SME Defined]
Quantity UOM: A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI E - C25709]"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:percent.value">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.value"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:percent.unit">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.unit"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.amount:percent.code">
      <path
            value="ManufacturedItemDefinition.component.constituent.amount.code"/>
      <min value="1"/>
      <mustSupport value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units"/>
      </binding>
    </element>
    <element id="ManufacturedItemDefinition.component.constituent.location">
      <path
            value="ManufacturedItemDefinition.component.constituent.location"/>
      <short value="Product Part Ingredient Physical Location"/>
      <definition
                  value="Identifies where the ingredient physically resides within the product part. [Source: SME Defined]
Examples: Intragranular, Extra granular, Blend"/>
      <mustSupport value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location"/>
      </binding>
    </element>
    <element
             id="ManufacturedItemDefinition.component.constituent.hasIngredient">
      <path
            value="ManufacturedItemDefinition.component.constituent.hasIngredient"/>
      <min value="1"/>
      <max value="1"/>
      <type>
        <code value="CodeableReference"/>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"/>
        <aggregation value="bundled"/>
      </type>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.property">
      <path value="ManufacturedItemDefinition.component.property"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="type.text"/>
        </discriminator>
        <description value="Slice based on value"/>
        <rules value="closed"/>
      </slicing>
      <min value="1"/>
      <type>
        <code value="BackboneElement"/>
      </type>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.property.type">
      <path value="ManufacturedItemDefinition.component.property.type"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.property.type.text">
      <path value="ManufacturedItemDefinition.component.property.type.text"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.property:PPiD">
      <path value="ManufacturedItemDefinition.component.property"/>
      <sliceName value="PPiD"/>
      <short value="Product Part Identifier"/>
      <definition
                  value="A submitter designated identifier that uniquely identifies the part within the drug product. [Source: SME Defined]
Examples: 1, A1, Red bead, Blue minitablet"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:PPiD.type.text">
      <path value="ManufacturedItemDefinition.component.property.type.text"/>
      <patternString value="Product Part Identifier"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:PPiD.value[x]">
      <path value="ManufacturedItemDefinition.component.property.value[x]"/>
      <min value="1"/>
      <type>
        <code value="CodeableConcept"/>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"/>
      </type>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.property:PPiDref">
      <path value="ManufacturedItemDefinition.component.property"/>
      <sliceName value="PPiDref"/>
      <short value="Product Part Identifier Reference"/>
      <definition
                  value="Identifies the parent or outer-level product part. [Source: SME Defined]
Example: A bead (Product Part Identifier = “B1”) has a seal coating (Product Part Identifier = “SCoat”) and is contained in a Hard HPMC capsule shell (Product Part Identifier “Cap Shell”). For the seal coating, Product Part Identifier Reference = “B1”, because the seal coat is applied to the bead."/>
      <min value="0"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:PPiDref.type.text">
      <path value="ManufacturedItemDefinition.component.property.type.text"/>
      <patternString value="Product Part Identifier Reference"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:PPiDref.value[x]">
      <path value="ManufacturedItemDefinition.component.property.value[x]"/>
      <min value="1"/>
      <type>
        <code value="CodeableConcept"/>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"/>
      </type>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.property:AddInfo">
      <path value="ManufacturedItemDefinition.component.property"/>
      <sliceName value="AddInfo"/>
      <short value="Product Part Additional Information"/>
      <definition
                  value="A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying.
Implementation note: This is represented in  markdown.  For multiple comments utilize markdwon formating for separation of notes."/>
      <min value="0"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:AddInfo.type.text">
      <path value="ManufacturedItemDefinition.component.property.type.text"/>
      <patternString value="Product Part Additional Information"/>
    </element>
    <element
             id="ManufacturedItemDefinition.component.property:AddInfo.value[x]">
      <path value="ManufacturedItemDefinition.component.property.value[x]"/>
      <min value="1"/>
      <type>
        <code value="markdown"/>
      </type>
      <mustSupport value="true"/>
    </element>
    <element id="ManufacturedItemDefinition.component.component">
      <path value="ManufacturedItemDefinition.component.component"/>
      <mustSupport value="true"/>
    </element>
  </differential>
</StructureDefinition>