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

## : PackagedProductDefinition - Drug - example - XML Representation

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    <PackagedProductDefinition xmlns="http://hl7.org/fhir">
      <id value="packagedproductdefinition-drug-pq-ex1"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq"/>
      </meta>
      <text>
        <status value="generated"/>
        <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PackagedProductDefinition</b><a name="packagedproductdefinition-drug-pq-ex1"> </a><a name="hcpackagedproductdefinition-drug-pq-ex1"> </a></p><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">Resource PackagedProductDefinition &quot;packagedproductdefinition-drug-pq-ex1&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PackagedProductDefinition-drug-pq.html">PackagedProductDefinition - Drug PQ</a></p></div><p><b>packageFor</b>: <a href="MedicinalProductDefinition-medicinalproductdefinition-drug-product-pq-ex1.html">MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1</a></p><p><b>description</b>: The commercial primary pack is a high-density polyethylene (HDPE) bottle with a child-resistant polypropylene (PP) screw cap.  Inside the bottle is a desiccant, containing silica gel. Induction seal membranes provide additional tamper evidence. For further details of the packaging components, see ‘P.7 Container Closure System for Drug Product’.</p><blockquote><p><b>packaging</b></p><p><b>type</b>: Box <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-packaging-type.html">Packaging Type</a>#100000073498)</span></p><p><b>material</b>: Cardboard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-package-material.html">Package Material</a>#200000003529)</span></p><h3>ShelfLifeStorages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Period[x]</b></td></tr><tr><td style="display: none">*</td><td>2 year<span style="background: LightGoldenRodYellow"> (Details: UCUM code a = 'a')</span></td></tr></table><p><b>manufacturer</b>: <a href="Organization-organization-drug-pq-ex1.html">Organization/organization-drug-pq-ex1</a> &quot;AAA Molybdenum Products, Inc.&quot;</p><blockquote><p><b>property</b></p><p><b>type</b>: Functional <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-package-property.html">Package Property Codes</a>#Functional)</span></p><p><b>value</b>: false</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Quality Standard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-package-property.html">Package Property Codes</a>#Quality Standard)</span></p><p><b>value</b>: USP &lt;661&gt; Plastic Packaging Systems and Their Materials of Construction <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-package-grade.html">Package Grade Codes</a>#USP)</span></p></blockquote><blockquote><p><b>packaging</b></p><p><b>type</b>: Tape <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#1d2344)</span></p><p><b>componentPart</b>: true</p><p><b>material</b>: Plastic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#200000003208)</span></p><p><b>manufacturer</b>: <a href="Organization-organization-drug-pq-ex1.html">Organization/organization-drug-pq-ex1</a> &quot;AAA Molybdenum Products, Inc.&quot;</p><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>property</b></p></blockquote></blockquote><blockquote><p><b>packaging</b></p><p><b>type</b>: Bottle <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-packaging-type.html">Packaging Type</a>#100000073497)</span></p><p><b>material</b>: Glass <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-package-material.html">Package Material</a>#200000003203)</span></p><p><b>manufacturer</b>: <a href="Organization-organization-drug-pq-ex1.html">Organization/organization-drug-pq-ex1</a> &quot;AAA Molybdenum Products, Inc.&quot;</p><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>containedItem</b></p></blockquote><blockquote><p><b>packaging</b></p></blockquote></blockquote></blockquote></div>
      </text>
      <packageFor>🔗
        <reference
                   value="MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"/>
      </packageFor>
      <description
                   value="The commercial primary pack is a high-density polyethylene (HDPE) bottle with a child-resistant polypropylene (PP) screw cap.  Inside the bottle is a desiccant, containing silica gel. Induction seal membranes provide additional tamper evidence. For further details of the packaging components, see ‘P.7 Container Closure System for Drug Product’."/>
      <packaging>
        <type>
          <coding>
            <system value="http://hl7.org/fhir/packaging-type"/>
            <code value="100000073498"/>
            <display value="Box"/>
          </coding>
        </type>
        <material>
          <coding>
            <system value="http://hl7.org/fhir/package-material"/>
            <code value="200000003529"/>
            <display value="Cardboard"/>
          </coding>
        </material>
        <shelfLifeStorage>
          <periodDuration>
            <value value="2"/>
            <unit value="year"/>
            <system value="http://unitsofmeasure.org"/>
            <code value="a"/>
          </periodDuration>
        </shelfLifeStorage>
        <manufacturer>🔗
          <reference value="Organization/organization-drug-pq-ex1"/>
        </manufacturer>
        <property>
          <type>
            <coding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/package-property"/>
              <code value="Functional"/>
              <display value="Functional"/>
            </coding>
          </type>
          <valueBoolean value="false"/>
        </property>
        <property>
          <type>
            <coding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/package-property"/>
              <code value="Quality Standard"/>
              <display value="Quality Standard"/>
            </coding>
          </type>
          <valueCodeableConcept>
            <coding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/package-grade"/>
              <code value="USP"/>
              <display
                       value="USP &lt;661&gt; Plastic Packaging Systems and Their Materials of Construction"/>
            </coding>
          </valueCodeableConcept>
        </property>
        <packaging>
          <type>
            <coding>
              <!--                     <system value="http://example.org/fhir/code/closureTypes"/> -->
              <system
                      value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
              <code value="1d2344"/>
              <display value="Tape"/>
            </coding>
          </type>
          <componentPart value="true"/>
          <material>
            <coding>
              <!--                     <system value="http://example.org/fhir/code/material"/> -->
              <system
                      value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
              <code value="200000003208"/>
              <display value="Plastic"/>
            </coding>
          </material>
          <manufacturer>🔗
            <reference value="Organization/organization-drug-pq-ex1"/>
          </manufacturer>
          <property>
            <type>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/package-property"/>
                <code value="Quality Specification"/>
                <display value="Quality Specification"/>
              </coding>
            </type>
            <valueCodeableConcept>
              <text value="Quality Specification for closure is described"/>
            </valueCodeableConcept>
          </property>
          <property>
            <type>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/package-property"/>
                <code value="Quality Standard"/>
                <display value="Quality Standard"/>
              </coding>
            </type>
            <valueCodeableConcept>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/package-grade"/>
                <code value="BP"/>
                <display value="Closure Quality Standard"/>
              </coding>
            </valueCodeableConcept>
          </property>
          <property>
            <type>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/package-property"/>
                <code value="Narrative"/>
                <display value="Narrative"/>
              </coding>
            </type>
            <valueCodeableConcept>
              <text
                    value="Closure - Suitability, protection, safety: conformance to criteria, performance, compabilitity"/>
            </valueCodeableConcept>
          </property>
          <property>
            <type>
              <coding>
                <!--   <system value="http://example.org/fhir/code/closureProperties"/> -->
                <system
                        value="http://terminology.hl7.org/CodeSystem/package-property"/>
                <code value="1123ss"/>
                <display value="Integrity Test"/>
              </coding>
            </type>
            <valueCodeableConcept>
              <text
                    value="Container–closure integrity test is any package leak test (either physicochemical or microbiological) that detects the presence of a package breach or gap."/>
            </valueCodeableConcept>
          </property>
        </packaging>
        <packaging>
          <type>
            <coding>
              <system value="http://hl7.org/fhir/packaging-type"/>
              <code value="100000073497"/>
              <display value="Bottle"/>
            </coding>
          </type>
          <material>
            <coding>
              <system value="http://hl7.org/fhir/package-material"/>
              <code value="200000003203"/>
              <display value="Glass"/>
            </coding>
          </material>
          <manufacturer>🔗
            <reference value="Organization/organization-drug-pq-ex1"/>
          </manufacturer>
          <property>
            <type>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/package-property"/>
                <code value="Quality Specification"/>
                <display value="Quality Specification"/>
              </coding>
            </type>
            <valueCodeableConcept>
              <text value="Quality Specification is described"/>
            </valueCodeableConcept>
          </property>
          <property>
            <type>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/package-property"/>
                <code value="Quality Standard"/>
                <display value="Quality Standard"/>
              </coding>
            </type>
            <valueCodeableConcept>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/package-grade"/>
                <code value="USP"/>
                <display
                         value="USP &lt;661&gt; Plastic Packaging Systems and Their Materials of Construction"/>
              </coding>
            </valueCodeableConcept>
          </property>
          <property>
            <type>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/package-property"/>
                <code value="Narrative"/>
                <display value="Narrative"/>
              </coding>
            </type>
            <valueCodeableConcept>
              <text
                    value="Suitability, protection, safety: conformance to criteria, performance, compabilitity"/>
            </valueCodeableConcept>
          </property>
          <property>
            <type>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/package-property"/>
                <code value="Container Size"/>
                <display value="Container Size"/>
              </coding>
            </type>
            <valueQuantity>
              <value value="250"/>
              <unit value="ml"/>
            </valueQuantity>
          </property>
          <containedItem>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/data-absent-reason">
                <valueCode value="unsupported"/>
              </extension>
            </item>
            <amount>
              <value value="100"/>
              <unit value="mg"/>
            </amount>
          </containedItem>
          <packaging>
            <type>
              <coding>
                <!--                         <system value="http://example.org/fhir/code/closureTypes"/> -->
                <system
                        value="http://terminology.hl7.org/CodeSystem/container-closure-type"/>
                <!--                         <code value="112344"/> -->
                <code value="Child Proof Cap"/>
                <display value="Child Proof Cap"/>
              </coding>
            </type>
            <componentPart value="true"/>
            <material>
              <coding>
                <!--                         <system value="http://example.org/fhir/code/material"/> -->
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="112344ss"/>
                <display value="PVC"/>
              </coding>
            </material>
            <manufacturer>🔗
              <reference value="Organization/organization-drug-pq-ex1"/>
            </manufacturer>
            <property>
              <type>
                <coding>
                  <system
                          value="http://terminology.hl7.org/CodeSystem/package-property"/>
                  <code value="Quality Specification"/>
                  <display value="Quality Specification"/>
                </coding>
              </type>
              <valueCodeableConcept>
                <text value="Quality Specification for closure is described"/>
              </valueCodeableConcept>
            </property>
            <property>
              <type>
                <coding>
                  <system
                          value="http://terminology.hl7.org/CodeSystem/package-property"/>
                  <code value="Quality Standard"/>
                  <display value="Quality Standard"/>
                </coding>
              </type>
              <valueCodeableConcept>
                <coding>
                  <system
                          value="http://terminology.hl7.org/CodeSystem/package-grade"/>
                  <code value="BP"/>
                  <display value="Closure Quality Standard"/>
                </coding>
              </valueCodeableConcept>
            </property>
            <property>
              <type>
                <coding>
                  <system
                          value="http://terminology.hl7.org/CodeSystem/package-property"/>
                  <code value="Narrative"/>
                  <display value="Narrative"/>
                </coding>
              </type>
              <valueCodeableConcept>
                <text
                      value="Closure - Suitability, protection, safety: conformance to criteria, performance, compabilitity"/>
              </valueCodeableConcept>
            </property>
            <property>
              <type>
                <coding>
                  <!-- <system value="http://example.org/fhir/code/closureProperties"/> -->
                  <system
                          value="http://terminology.hl7.org/CodeSystem/package-property"/>
                  <code value="1123ss"/>
                  <display value="Integrity Test"/>
                </coding>
              </type>
              <valueCodeableConcept>
                <text
                      value="Container–closure integrity test is any package leak test (either physicochemical or microbiological) that detects the presence of a package breach or gap."/>
              </valueCodeableConcept>
            </property>
          </packaging>
        </packaging>
      </packaging>
    </PackagedProductDefinition>