Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundle-product-process-validation-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-process-validation-pq"/>
</meta>
<language value="en"/>
<type value="collection"/>
<entry>
<fullUrl value="urn:uuid:1h1h1h1h-1h1h-1h1h-1h1h-1h1h1h1h1h1h"/>
<resource>
<MedicinalProductDefinition>
<id value="medicinalproductdefinition-drug-product-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_medicinalproductdefinition-drug-product-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition medicinalproductdefinition-drug-product-pq-ex1</b></p><a name="medicinalproductdefinition-drug-product-pq-ex1"> </a><a name="hcmedicinalproductdefinition-drug-product-pq-ex1"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-MedicinalProductDefinition-drug-product-pq.html">MedicinalProductDefinition - Drug Product PQ</a></p></div><p><b>identifier</b>: <code>http://example.org/identifiers/product</code>/PROD-12345</p><p><b>combinedPharmaceuticalDoseForm</b>: <span title="Codes:{http://standardterms.edqm.eu 10219000}">Tablet</span></p><p><b>route</b>: <span title="Codes:{http://standardterms.edqm.eu 20053000}">Oral use</span></p><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ProductName</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>Stelbatolol 10mg Tablets</td><td><span title="Codes:{http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-product-name-type-pq INV}">Invented Name</span></td></tr></table></div>
</text>
<identifier>
<system value="http://example.org/identifiers/product"/>
<value value="PROD-12345"/>
</identifier>
<combinedPharmaceuticalDoseForm>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="10219000"/>
<display value="Tablet"/>
</coding>
</combinedPharmaceuticalDoseForm>
<route>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="20053000"/>
<display value="Oral use"/>
</coding>
</route>
<name>
<productName value="Stelbatolol 10mg Tablets"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-product-name-type-pq"/>
<code value="INV"/>
<display value="Invented Name"/>
</coding>
</type>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:2h2h2h2h-2h2h-2h2h-2h2h-2h2h2h2h2h2h"/>
<resource>
<Ingredient>
<id value="ingredient-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Ingredient-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-drug-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-drug-pq-ex1</b></p><a name="ingredient-drug-pq-ex1"> </a><a name="hcingredient-drug-pq-ex1"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Ingredient-drug-pq.html">Ingredient - Drug Pq</a></p></div><p><b>status</b>: Active</p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/ingredient-role 100000072072}">Active</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="SubstanceDefinition-substancedefinition-component-substance-drug-pq-ex1.html">SubstanceDefinition: status = Active</a></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<role>
<coding>
<system value="http://hl7.org/fhir/ingredient-role"/>
<code value="100000072072"/>
<display value="Active"/>
</coding>
</role>
<substance>
<code>
<reference>🔗
<reference
value="SubstanceDefinition/substancedefinition-component-substance-drug-pq-ex1"/>
</reference>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:3h3h3h3h-3h3h-3h3h-3h3h-3h3h3h3h3h3h"/>
<resource>
<SubstanceDefinition>
<id value="substancedefinition-component-substance-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_substancedefinition-component-substance-drug-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition substancedefinition-component-substance-drug-pq-ex1</b></p><a name="substancedefinition-component-substance-drug-pq-ex1"> </a><a name="hcsubstancedefinition-component-substance-drug-pq-ex1"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubstanceDefinition-component-substance-drug-pq.html">SubstanceDefinition - Component Substance Drug PQ</a></p></div><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>manufacturer</b>: <a href="Organization-organization-drug-pq-ex1.html">Organization AAA Molybdenum Products, Inc.</a></p><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td></tr><tr><td style="display: none">*</td><td>Stelbatolol Hydrochloride</td></tr></table></div>
</text>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<manufacturer>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</manufacturer>
<name>
<name value="Stelbatolol Hydrochloride"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:4h4h4h4h-4h4h-4h4h-4h4h-4h4h4h4h4h4h"/>
<resource>
<Medication>
<id value="medication-batch-information-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Medication-batch-information-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Medication_medication-batch-information-drug-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: Medication medication-batch-information-drug-pq-ex1</b></p><a name="medication-batch-information-drug-pq-ex1"> </a><a name="hcmedication-batch-information-drug-pq-ex1"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Medication-batch-information-drug-pq.html">Medication - Batch Information Drug PQ</a></p></div><p><b>code</b>: <span title="Codes:"></span></p><blockquote><p><b>batch</b></p><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p>manufacturingDate</blockquote><p><b>value</b>: 2020-06</p><blockquote><p><b>url</b></p>batchQuantity</blockquote><p><b>value</b>: 100100 tablets</p><blockquote><p><b>url</b></p>batchUtilization</blockquote><p><b>value</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C133990}">Production</span></p><blockquote><p><b>url</b></p>assignedManufacturer</blockquote><p><b>value</b>: <a href="Organization-organization-drug-pq-ex1.html">Organization AAA Molybdenum Products, Inc.</a></p><p><b>closureSystemDescription</b>: 100 cc HDPE Bottle 2 g desiccant</p><blockquote><p><b>url</b></p>container</blockquote></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Designation PQ</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/batch-designation maximum}">Maximum</span></p><p><b>Extension - Batch Number of Vials PQ</b>: 3</p><p><b>Extension - Batch Substance Batch PQ</b>: <a href="Substance-substance-drug-pq-ex1.html">Substance </a></p><p><b>Extension - Packaging Date PQ</b>: 2020-08</p><p><b>Extension - Packaging Site PQ</b>: <a href="Organization-organization-drug-pq-ex1.html">Organization AAA Molybdenum Products, Inc.</a></p><p><b>Extension - Actual Yield PQ</b>: 4.81 kg</p><p><b>Extension - Actual Yield Unfiltered PQ</b>: 4.91 kg</p><p><b>Extension Target Fill Weight PQ</b>: 30 g</p><p><b>lotNumber</b>: 33445</p></blockquote></div>
</text>
<code>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq">
<valueReference>🔗
<reference
value="MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"/>
</valueReference>
</extension>
</code>
<batch>
<extension
url="http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch">
<extension url="manufacturingDate">
<valueDateTime value="2020-06"/>
</extension>
<extension url="batchQuantity">
<valueQuantity>
<value value="100100"/>
<unit value="tablets"/>
</valueQuantity>
</extension>
<extension url="batchUtilization">
<valueCodeableConcept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C133990"/>
<display value="Commercial"/>
</coding>
<text value="Production"/>
</valueCodeableConcept>
</extension>
<extension url="assignedManufacturer">
<valueReference>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</valueReference>
</extension>
<extension url="container">
<extension url="closureSystemDescription">
<valueString value="100 cc HDPE Bottle 2 g desiccant"/>
</extension>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq">
<valueDateTime value="2019-09-08"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-designation-pq">
<valueCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/batch-designation"/>
<code value="maximum"/>
<display value="Maximum"/>
</coding>
<text value="Maximum"/>
</valueCodeableConcept>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-number-of-vials-pq">
<valuePositiveInt value="3"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-substance-batch-pq">
<valueReference>🔗
<reference value="Substance/substance-drug-pq-ex1"/>
</valueReference>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq">
<valueDateTime value="2020-08"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq">
<valueReference>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</valueReference>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq">
<valueQuantity>
<value value="4.81"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-unfiltered-pq">
<valueQuantity>
<value value="4.91"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-target-fill-weight-pq">
<valueQuantity>
<value value="30"/>
<unit value="g"/>
</valueQuantity>
</extension>
<lotNumber value="33445"/>
</batch>
</Medication>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:5h5h5h5h-5h5h-5h5h-5h5h-5h5h5h5h5h5h"/>
<resource>
<Substance>
<id value="substance-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Substance_substance-drug-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: Substance substance-drug-pq-ex1</b></p><a name="substance-drug-pq-ex1"> </a><a name="hcsubstance-drug-pq-ex1"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Substance-drug-pq.html">Substance - Drug PQ</a></p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><ul><li>manufacturingDate: 2019-09-07</li><li>batchQuantity: 5 kg</li><li>batchUtilization: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C133991}">Development</span></li><li>assignedManufacturer: <a href="Organization-organization-drug-pq-ex1.html">Organization AAA Molybdenum Products, Inc.</a></li></ul></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: CAT1</p><p><b>instance</b>: false</p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Substance</span></td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch">
<extension url="manufacturingDate">
<valueDateTime value="2019-09-07"/>
</extension>
<extension url="batchQuantity">
<valueQuantity>
<value value="5"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension url="batchUtilization">
<valueCodeableConcept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C133991"/>
<display value="Development"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="assignedManufacturer">
<valueReference>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq">
<valueDateTime value="2019-09-08"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq">
<valueDateTime value="2022-09-08"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq">
<valueQuantity>
<value value="4.8"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<identifier>
<value value="CAT1"/>
</identifier>
<instance value="false"/>
<code>
<concept>
<text value="Substance"/>
</concept>
</code>
</Substance>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:6h6h6h6h-6h6h-6h6h-6h6h-6h6h6h6h6h6h"/>
<resource>
<PlanDefinition>
<id value="plandefinition-drug-pq-ex1-validation-protocol"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PlanDefinition_plandefinition-drug-pq-ex1-validation-protocol"> </a>
<table class="narrative-table">
<tbody>
<tr>
<th colspan="2" scope="row" class="row-header">Metadata</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">DP PROCESS VALIDATION</td>
</tr>
<tr>
<th scope="row" class="row-header">Subject Type</th>
<td class="content-container"><a href="MedicinalProductDefinition-medicinalproductdefinition-drug-product-pq-ex1.html">MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use</a></td>
</tr>
<tr>
<th scope="row" class="row-header">Description</th>
<td class="content-container"><div><p>Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...</p>
</div></td>
</tr>
<tr>
<th scope="row" class="row-header">Type</th>
<td class="content-container">
Workflow Definition
Process Validation
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Formulation Buffer Preparation Process Parameter Step</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Formulation Buffer Preparation Process Parameter Step
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Formulation Buffer Preparation Process Parameter Step</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">FormulationBufferPreparationProcessParameterStep
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Conclusion
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Formulation Buffer Preparation Performance Indicator Results</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Formulation Buffer Preparation Performance Indicator Results
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Performance Indicator Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">???</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">???
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-939ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Thawing and Formulation Process Parameter Results</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Thawing and Formulation Process Parameter Resultss
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Thawing and Formulation Process Parameter Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">???</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">???
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/74515a3c-5034-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe2-91c2-2d16-47cb5b295e72</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/fc27b5d5-9fe1-92c2-2d06-47cb5b295e73</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Thawing and Formulation Performance Indicator Results</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Thawing and Formulation Performance Indicator Results
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Thawing and Formulation Performance Indicator Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">???</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">???
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-47cb5b295e72</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/74515a3c-5134-448a-9c19-939ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515b4c-5134-448a-9c19-949ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: ???)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958434</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Bioburden Reduction Filtration Process Parameter Results</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Bioburden Reduction Filtration Process Parameter Results
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Process Parameter Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Bioburden Reduction Filtration Performance Indicator Results</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Bioburden Reduction Filtration Performance Indicator Results
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Performance Indicator Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Performance Indicator Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Media Challenge Hold Times</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Media Challenge Hold Times
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Media Challenge Hold Times)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Media Challenge Results</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Media Challenge Results
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Media Challenge Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Media Challenge Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Filtered Formulated Drug Product Performance Indicator Results</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Filtered Formulated Drug Product Performance Indicator Results
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Fill Weight Summary</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Fill Weight Summary
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Fill Weight Summary)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Filling Homogeneity Quality Attributes</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Filling Homogeneity Quality Attributes
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Filling Homogeneity Quality Attributes)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Conclusion
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Filling Results Summary</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Filling Results Summary
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Filling Results Summary)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Filling Results Summary)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Statistical Evaluation of Homogeneity Data</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Statistical Evaluation of Homogeneity Data
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Statistical Evaluation of Homogeneity Data)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Statistical Evaluation of Homogeneity Data)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Consistency of the Lyophilization Process</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Consistency of the Lyophilization Process
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Consistency of the Lyophilization Process)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Consistency of the Lyophilization Process)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Definition
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bd</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Lyophilization Homogeneity</td>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">
Lyophilization Homogeneity Results
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Lyophilization Homogeneity)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Lyophilization Homogeneity)</th>
</tr>
<tr>
<th scope="row" class="row-header">Code</th>
<td class="content-container">Test
</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">Generated using version 0.5.4 of the sample-content-ig Liquid templates</th>
</tr>
</tbody>
</table>
</div>
</text>
<url
value="http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol"/>
<title value="DP PROCESS VALIDATION"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/plan-definition-type"/>
<code value="workflow-definition"/>
<display value="Workflow Definition"/>
</coding>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type"/>
<code value="process-validation"/>
<display value="Process Validation"/>
</coding>
</type>
<status value="active"/>
<subjectReference>🔗
<reference
value="MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"/>
</subjectReference>
<description
value="Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies..."/>
<action>
<title
value="Formulation Buffer Preparation Process Parameter Step"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="FormulationBufferPreparationProcessParameterStep"/>
<display
value="Formulation Buffer Preparation Process Parameter Step"/>
</coding>
<text
value="Formulation Buffer Preparation Process Parameter Step"/>
</code>
<action>
<title
value="Formulation Buffer Preparation Process Parameter Step"/>
<code>
<text value="FormulationBufferPreparationProcessParameterStep"/>
</code>
<action>
<code>
<text value="Conclusion"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"/>
</action>
</action>
</action>
<action>
<title
value="Formulation Buffer Preparation Performance Indicator Results"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code
value="FormulationBufferPreparationPerformanceIndicatorStep"/>
<display
value="Formulation Buffer Preparation Performance Indicator Results"/>
</coding>
</code>
<action>
<title value="???"/>
<code>
<text value="???"/>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-939ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958424"/>
</action>
</action>
</action>
<action>
<title value="Thawing and Formulation Process Parameter Results"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="ThawingandFormulationProcessParameterResultsStep"/>
<display
value="Thawing and Formulation Process Parameter Resultss"/>
</coding>
</code>
<action>
<title value="???"/>
<code>
<text value="???"/>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/74515a3c-5034-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe2-91c2-2d16-47cb5b295e72"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/fc27b5d5-9fe1-92c2-2d06-47cb5b295e73"/>
</action>
</action>
</action>
<action>
<title
value="Thawing and Formulation Performance Indicator Results"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code
value="ThawingandFormulationPerformanceIndicatorResultsStep"/>
<display
value="Thawing and Formulation Performance Indicator Results"/>
</coding>
</code>
<action>
<title value="???"/>
<code>
<text value="???"/>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-47cb5b295e72"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/74515a3c-5134-448a-9c19-939ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515b4c-5134-448a-9c19-949ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958434"/>
</action>
</action>
</action>
<action>
<title
value="Bioburden Reduction Filtration Process Parameter Results"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code
value="BioburdenReductionFiltrationProcessParameterResultsStep"/>
<display
value="Bioburden Reduction Filtration Process Parameter Results"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434"/>
</action>
</action>
<action>
<title
value="Bioburden Reduction Filtration Performance Indicator Results"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code
value="BioburdenReductionFiltrationPerformanceIndicatorResultsStep"/>
<display
value="Bioburden Reduction Filtration Performance Indicator Results"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434"/>
</action>
</action>
<action>
<title value="Media Challenge Hold Times"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="MediaChallengeHoldTimesStep"/>
<display value="Media Challenge Hold Times"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434"/>
</action>
</action>
<action>
<title value="Media Challenge Results"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="MediaChallengeResultsStep"/>
<display value="Media Challenge Results"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524"/>
</action>
</action>
<action>
<title
value="Filtered Formulated Drug Product Performance Indicator Results"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code
value="FilteredFormulatedDrugProductPerformanceIndicatorResultsStep"/>
<display
value="Filtered Formulated Drug Product Performance Indicator Results"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424"/>
</action>
</action>
<action>
<title value="Fill Weight Summary"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="FillWeightSummaryStep"/>
<display value="Fill Weight Summary"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524"/>
</action>
</action>
<action>
<title value="Filling Homogeneity Quality Attributes"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="FillingHomogeneityQualityAttributesStep"/>
<display value="Filling Homogeneity Quality Attributes"/>
</coding>
<text value="Filling Homogeneity Quality Attributes"/>
</code>
<action>
<code>
<text value="Conclusion"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424"/>
</action>
</action>
<action>
<title value="Filling Results Summary"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="FillingResultsSummaryStep"/>
<display value="Filling Results Summary"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524"/>
</action>
</action>
<action>
<title value="Statistical Evaluation of Homogeneity Data"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="StatisticalEvaluationOfHomogeneityDataStep"/>
<display value="Statistical Evaluation of Homogeneity Data"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524"/>
</action>
</action>
<action>
<title value="Consistency of the Lyophilization Process"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="ConsistencyoftheLyophilizationProcessStep"/>
<display value="Consistency of the Lyophilization Process"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72"/>
</action>
<action>
<code>
<text value="Definition"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bd"/>
</action>
</action>
<action>
<title value="Lyophilization Homogeneity"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
<code value="LyophilizationHomogeneityStep"/>
<display value="Lyophilization Homogeneity Results"/>
</coding>
</code>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424"/>
</action>
</action>
</PlanDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:7h7h7h7h-7h7h-7h7h-7h7h-7h7h7h7h7h7h"/>
<resource>
<ActivityDefinition>
<id value="activitydefinition-test-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ActivityDefinition_activitydefinition-test-drug-pq-ex1"> </a>
<table class="narrative-table">
<tbody>
<tr>
<th colspan="2" scope="row" class="row-header">Metadata</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ.</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">Generated using version 0.5.4 of the sample-content-ig Liquid templates</th>
</tr>
</tbody>
</table>
</div>
</text>
<url
value="http://example-server.com/fhir/ActivityDefinition/activitydefinition-test-drug-pq-ex1"/>
<title
value="Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ."/>
<status value="active"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:8h8h8h8h-8h8h-8h8h-8h8h-8h8h8h8h8h8h"/>
<resource>
<ObservationDefinition>
<id value="Assay"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_Assay"> </a><p class="res-header-id"><b>Generated Narrative: ObservationDefinition Assay</b></p><a name="Assay"> </a><a name="hcAssay"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ObservationDefinition-test-method-drug-pq.html">ObservationDefinition - Test Method PQ</a></p></div><p><b>status</b>: Active</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example ASSAY}">Assay</span></p><p><b>method</b>: <span title="Codes:">Assay by UHPLC</span></p></div>
</text>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
<text value="Assay"/>
</code>
<method>
<text value="Assay by UHPLC"/>
</method>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9h9h9h9h-9h9h-9h9h-9h9h-9h9h9h9h9h9h"/>
<resource>
<DeviceDefinition>
<id value="devicedefinition-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DeviceDefinition-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="DeviceDefinition_devicedefinition-drug-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: DeviceDefinition devicedefinition-drug-pq-ex1</b></p><a name="devicedefinition-drug-pq-ex1"> </a><a name="hcdevicedefinition-drug-pq-ex1"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-DeviceDefinition-drug-pq.html">DeviceDefinition - Drug PQ</a></p></div><h3>DeviceNames</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>Rotating Impeller with 1.5mm screen</td><td>Registered name</td></tr></table><h3>Properties</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/device-property Maximum Speed}">Maximum Speed</span></td><td>5000 RPM</td></tr></table></div>
</text>
<deviceName>
<name value="Rotating Impeller with 1.5mm screen"/>
<type value="registered-name"/>
</deviceName>
<property>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/device-property"/>
<code value="Maximum Speed"/>
<display value="Maximum Speed"/>
</coding>
</type>
<valueQuantity>
<value value="5000"/>
<unit value="RPM"/>
</valueQuantity>
</property>
</DeviceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:0j0j0j0j-0j0j-0j0j-0j0j-0j0j0j0j0j0j"/>
<resource>
<DiagnosticReport>
<id value="diagnosticreport-analysis-drug-pq-stability-prod"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="DiagnosticReport_diagnosticreport-analysis-drug-pq-stability-prod"> </a><p class="res-header-id"><b>Generated Narrative: DiagnosticReport diagnosticreport-analysis-drug-pq-stability-prod</b></p><a name="diagnosticreport-analysis-drug-pq-stability-prod"> </a><a name="hcdiagnosticreport-analysis-drug-pq-stability-prod"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-DiagnosticReport-analysis-drug-pq.html">DiagnosticReport - Analysis Drug PQ</a></p></div><h2><span title="Codes:{http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type Stability Study Report - 18 months}">Stability Study Report - 18 months</span> </h2><table class="grid"><tr><td>When For</td><td>2020-12</td></tr><tr><td>Performer</td><td> <a href="Organization-organization-drug-pq-ex1.html">Organization AAA Molybdenum Products, Inc.</a></td></tr><tr><td>Identifier</td><td> <code>https://eudract.europa.eu/example/identifier</code>/ABC1234</td></tr></table><p><b>Report Details</b></p><table class="grid"><tr><td><b>Code</b></td><td><b>Value</b></td><td><b>Flags</b></td><td><b>When For</b></td></tr><tr><td><a href="Observation-observation-test-result-longterm25c-initial-1.html"><span title="Codes:">Test Components - Long-term 25C etc - Initial (XYZ)</span></a></td><td/><td>Final</td><td>2023-01-01 12:00:00+0000</td></tr></table><div><p>The samples have been assessed for initial period; no shelf life determined.</p>
</div></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>🔗
<reference
value="PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol"/>
</valueReference>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq">
<valueCodeableConcept>
<text
value="information about statistical model utilized to interpret stability study results"/>
</valueCodeableConcept>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq">
<valueCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/container-orientation"/>
<code value="horizontal"/>
<display value="horizontal"/>
</coding>
<text value="Horizontal"/>
</valueCodeableConcept>
</extension>
<identifier>
<system value="https://eudract.europa.eu/example/identifier"/>
<value value="ABC1234"/>
</identifier>
<status value="final"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type"/>
<code value="Stability Study Report - 18 months"/>
<display value="Stability Study Report - 18 months"/>
</coding>
</code>
<effectiveDateTime value="2020-12">
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq">
<valueCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/time-point-description"/>
<code value="Delayed Start Code"/>
<display value="Delayed Start Code"/>
</coding>
<text value="Refrigerated delayed testing"/>
</valueCodeableConcept>
</extension>
</effectiveDateTime>
<performer>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</performer>
<result>🔗
<reference
value="Observation/observation-test-result-longterm25c-initial-1"/>
</result>
<conclusion
value="The samples have been assessed for initial period; no shelf life determined."/>
</DiagnosticReport>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:1j1j1j1j-1j1j-1j1j-1j1j-1j1j1j1j1j1j"/>
<resource>
<Procedure>
<id value="procedure-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Procedure-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Procedure_procedure-drug-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: Procedure procedure-drug-pq-ex1</b></p><a name="procedure-drug-pq-ex1"> </a><a name="hcprocedure-drug-pq-ex1"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Procedure-drug-pq.html">Procedure - Drug PQ</a></p></div><p><b>identifier</b>: Run 1</p><p><b>status</b>: Completed</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example MediaChallengeRun}">Media Challenge Run</span></p><p><b>subject</b>: Drug product</p></div>
</text>
<identifier>
<value value="Run 1"/>
</identifier>
<status value="completed"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="MediaChallengeRun"/>
<display value="Media Challenge Run"/>
</coding>
</code>
<subject>
<extension
url="http://hl7.org/fhir/StructureDefinition/alternate-reference">
<valueReference>🔗
<reference
value="MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"/>
</valueReference>
</extension>
<display value="Drug product"/>
</subject>
</Procedure>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:2j2j2j2j-2j2j-2j2j-2j2j-2j2j2j2j2j2j"/>
<resource>
<Observation>
<id value="observation-test-result-lt25c-i1-degradation-imp-total"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Observation_observation-test-result-lt25c-i1-degradation-imp-total"> </a><p class="res-header-id"><b>Generated Narrative: Observation observation-test-result-lt25c-i1-degradation-imp-total</b></p><a name="observation-test-result-lt25c-i1-degradation-imp-total"> </a><a name="hcobservation-test-result-lt25c-i1-degradation-imp-total"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Observation-test-result-drug-pq.html">Observation - Test Result Drug PQ</a></p></div><p><b>status</b>: Final</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example DGP}">Degradation Products</span></p><p><b>subject</b>: <a href="Medication-medication-batch-information-drug-pq-ex1.html">Medication </a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Organization-organization-drug-pq-ex1.html">Organization AAA Molybdenum Products, Inc.</a></p><p><b>value</b>: 0.801 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example IMP}">Impurity</span></td><td><span title="Codes:">Total Degradation Impurities</span></td></tr></table></div>
</text>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>🔗
<reference
value="Medication/medication-batch-information-drug-pq-ex1"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</performer>
<valueQuantity>
<value value="0.801"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Total Degradation Impurities"/>
</valueCodeableConcept>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:3j3j3j3j-3j3j-3j3j-3j3j-3j3j3j3j3j3j"/>
<resource>
<Organization>
<id value="organization-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_organization-drug-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: Organization organization-drug-pq-ex1</b></p><a name="organization-drug-pq-ex1"> </a><a name="hcorganization-drug-pq-ex1"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Organization-drug-pq.html">Organization - Drug PQ</a></p></div><p><b>identifier</b>: <a href="http://terminology.hl7.org/7.1.0/NamingSystem-FEI.html" title=""A FDA Establishment Identifier or Firm Establishment Identifier (FEI) is an FDA system generated number used to identify a firm. FDA systems interact, occasionally creating multiple records (FEIs) for one firm. Upon evaluation, these numbers are merged into one surviving FEI which is used to identify the firm. The remaining FEIs become children of the surviving FEI and are not used to identify the firm."
For more information, see [https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=common.faq](https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=common.faq).">FDA Establishment Identifier</a>/3003040516</p><p><b>active</b>: true</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type drug-substance-manufacture}">Drug Substance Manufacture</span></p><p><b>name</b>: AAA Molybdenum Products, Inc.</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>7233 W 116th Pl Ste C Broomfield Colorado 80020 USA </td></tr></table></div>
</text>
<identifier>
<system value="urn:oid:2.16.840.1.113883.4.82"/>
<value value="3003040516"/>
</identifier>
<active value="true"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type"/>
<code value="drug-substance-manufacture"/>
<display value="Drug Substance Manufacture"/>
</coding>
</type>
<name value="AAA Molybdenum Products, Inc."/>
<contact>
<address>
<line value="7233 W 116th Pl"/>
<line value="Ste C"/>
<city value="Broomfield"/>
<state value="Colorado"/>
<postalCode value="80020"/>
<country value="USA"/>
</address>
</contact>
</Organization>
</resource>
</entry>
</Bundle>
IG © 2023+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0.
Generated
2026-05-10
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