Pharmaceutical Quality (Industry)
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This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, 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></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-cs-packageProperty-local-pq.html">CodeSystem - Package Property</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-cs-packageProperty-local-pq.html">CodeSystem - Package Property</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-cs-grade-local-pq.html">CodeSystem - Grade</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"> (closureTypes#1d2344)</span></p><p><b>componentPart</b>: true</p><p><b>material</b>: Plastic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (material#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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq"/>
          <code value="Functional"/>
          <display value="Functional"/>
        </coding>
      </type>
      <valueBoolean value="false"/>
    </property>
    <property>
      <type>
        <coding>
          <system
                  value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq"/>
          <code value="Quality Standard"/>
          <display value="Quality Standard"/>
        </coding>
      </type>
      <valueCodeableConcept>
        <coding>
          <system
                  value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-grade-local-pq"/>
          <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"/>
          <code value="1d2344"/>
          <display value="Tape"/>
        </coding>
      </type>
      <componentPart value="true"/>
      <material>
        <coding>
          <system value="http://example.org/fhir/code/material"/>
          <code value="200000003208"/>
          <display value="Plastic"/>
        </coding>
      </material>
      <manufacturer>🔗 
        <reference value="Organization/organization-drug-pq-ex1"/>
      </manufacturer>
      <property>
        <type>
          <coding>
            <system
                    value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq"/>
            <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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq"/>
            <code value="Quality Standard"/>
            <display value="Quality Standard"/>
          </coding>
        </type>
        <valueCodeableConcept>
          <coding>
            <system
                    value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-grade-local-pq"/>
            <code value="BP"/>
            <display value="Closure Quality Standard"/>
          </coding>
        </valueCodeableConcept>
      </property>
      <property>
        <type>
          <coding>
            <system
                    value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq"/>
            <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"/>
            <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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq"/>
            <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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq"/>
            <code value="Quality Standard"/>
            <display value="Quality Standard"/>
          </coding>
        </type>
        <valueCodeableConcept>
          <coding>
            <system
                    value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-grade-local-pq"/>
            <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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq"/>
            <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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq"/>
            <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"/>
            <code value="112344"/>
            <display value="Child Proof Cap"/>
          </coding>
        </type>
        <componentPart value="true"/>
        <material>
          <coding>
            <system value="http://example.org/fhir/code/material"/>
            <code value="112344ss"/>
            <display value="PVC"/>
          </coding>
        </material>
        <manufacturer>🔗 
          <reference value="Organization/organization-drug-pq-ex1"/>
        </manufacturer>
        <property>
          <type>
            <coding>
              <system
                      value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq"/>
              <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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq"/>
              <code value="Quality Standard"/>
              <display value="Quality Standard"/>
            </coding>
          </type>
          <valueCodeableConcept>
            <coding>
              <system
                      value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-grade-local-pq"/>
              <code value="BP"/>
              <display value="Closure Quality Standard"/>
            </coding>
          </valueCodeableConcept>
        </property>
        <property>
          <type>
            <coding>
              <system
                      value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-packageProperty-local-pq"/>
              <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"/>
              <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>