Pharmaceutical Quality (Industry)
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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

: Example: Bundle – Substance Batch Information - XML Representation

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  <!--  Substance Batch Info  -->
<Bundle xmlns="http://hl7.org/fhir">
  <!-- id value="substance-batch-analysis"/ -->
  <id value="bundle-drug-substance-batch-info-pq-ex1"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-batch-info-pq"/>
  </meta>
  <type value="collection"/>
  <entry>
    <fullUrl value="urn:uuid:8dae93e0-048d-35a4-71ea-7c603184a130"/>
    <resource>
      <SubstanceDefinition>
        <!-- substance1 -->
        <id value="8dae93e0-048d-35a4-71ea-7c603184a130"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_8dae93e0-048d-35a4-71ea-7c603184a130"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="8dae93e0-048d-35a4-71ea-7c603184a130"> </a><a name="hc8dae93e0-048d-35a4-71ea-7c603184a130"> </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 SubstanceDefinition &quot;8dae93e0-048d-35a4-71ea-7c603184a130&quot; </p></div><p><b>manufacturer</b>: See on this page: Organization/3d399cbc-244e-9b5f-838b-b7daa0489330</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</td></tr></table></div>
        </text>
        <manufacturer>
          <!-- Organization/substance-manufacturer -->
          <reference
                     value="Organization/3d399cbc-244e-9b5f-838b-b7daa0489330"/>
        </manufacturer>
        <name>
          <name value="Stelbatolol"/>
        </name>
      </SubstanceDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:3d399cbc-244e-9b5f-838b-b7daa0489330"/>
    <resource>
      <Organization>
        <!-- substance-manufacturer -->
        <id value="3d399cbc-244e-9b5f-838b-b7daa0489330"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_3d399cbc-244e-9b5f-838b-b7daa0489330"> </a><p><b>Generated Narrative: Organization</b><a name="3d399cbc-244e-9b5f-838b-b7daa0489330"> </a><a name="hc3d399cbc-244e-9b5f-838b-b7daa0489330"> </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 Organization &quot;3d399cbc-244e-9b5f-838b-b7daa0489330&quot; </p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.4.82</code>/3003040516</p><p><b>active</b>: true</p><p><b>type</b>: Drug Substance Manufacture <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-organization-type.html">Pharmaceutical Organization Type Codes</a>#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>
          <!--  FDA establishment 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>
  <entry>
    <fullUrl value="urn:uuid:87ef899b-14dd-26b7-7416-7ec1d01b62a1"/>
    <resource>
      <Substance>
        <!-- substance-dxpq-ex1 -->
        <id value="87ef899b-14dd-26b7-7416-7ec1d01b62a1"/>
        <text>
          <status value="extensions"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1"> </a><p><b>Generated Narrative: Substance</b><a name="87ef899b-14dd-26b7-7416-7ec1d01b62a1"> </a><a name="hc87ef899b-14dd-26b7-7416-7ec1d01b62a1"> </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 Substance &quot;87ef899b-14dd-26b7-7416-7ec1d01b62a1&quot; </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2020-01</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 120 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Production <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C133990 &quot;Commercial&quot;)</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: See on this page: Organization/3d399cbc-244e-9b5f-838b-b7daa0489330</p></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 - Manufacturing Process PQ</b>: <span>: Process 1.1</span></p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: CAT1</p><p><b>instance</b>: true</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>See on this page: SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130</td></tr></table></div>
        </text>
        <!--  was actual-batch-substance  -->
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch">
          <extension url="manufacturingDate">
            <valueDateTime value="2020-01"/>
          </extension>
          <extension url="batchQuantity">
            <valueQuantity>
              <value value="120"/>
              <unit value="kg"/>
            </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>
              <!-- Organization/substance-manufacturer -->
              <reference
                         value="Organization/3d399cbc-244e-9b5f-838b-b7daa0489330"/>
            </valueReference>
          </extension>
        </extension>
        <!--  local extensions  -->
        <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-manufacturing-process-pq">
          <valueReference>
            <display value="Process 1.1"/>
          </valueReference>
        </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="true"/>
        <code>
          <reference>
            <!-- SubstanceDefinition/substance1 -->
            <reference
                       value="SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130"/>
          </reference>
        </code>
      </Substance>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:6412c5d4-1b7d-8405-85dc-75dbaa300ea4"/>
    <resource>
      <Substance>
        <!-- actual-batch-substance-2 -->
        <id value="6412c5d4-1b7d-8405-85dc-75dbaa300ea4"/>
        <text>
          <status value="extensions"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4"> </a><p><b>Generated Narrative: Substance</b><a name="6412c5d4-1b7d-8405-85dc-75dbaa300ea4"> </a><a name="hc6412c5d4-1b7d-8405-85dc-75dbaa300ea4"> </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 Substance &quot;6412c5d4-1b7d-8405-85dc-75dbaa300ea4&quot; </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2020-02</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 120 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Production <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C133990 &quot;Commercial&quot;)</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: See on this page: Organization/3d399cbc-244e-9b5f-838b-b7daa0489330</p></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>: CAT2</p><p><b>instance</b>: true</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>See on this page: SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130</td></tr></table></div>
        </text>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch">
          <extension url="manufacturingDate">
            <valueDateTime value="2020-02"/>
          </extension>
          <extension url="batchQuantity">
            <valueQuantity>
              <value value="120"/>
              <unit value="kg"/>
            </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>
              <!-- Organization/substance-manufacturer -->
              <reference
                         value="Organization/3d399cbc-244e-9b5f-838b-b7daa0489330"/>
            </valueReference>
          </extension>
        </extension>
        <!--  local extensions  -->
        <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="CAT2"/>
        </identifier>
        <instance value="true"/>
        <code>
          <reference>
            <!-- SubstanceDefinition/substance1 -->
            <reference
                       value="SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130"/>
          </reference>
        </code>
      </Substance>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:ef17cff1-6586-a4a4-9168-2602140548d7"/>
    <resource>
      <Substance>
        <!-- actual-batch-substance-3 -->
        <id value="ef17cff1-6586-a4a4-9168-2602140548d7"/>
        <text>
          <status value="extensions"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Substance_ef17cff1-6586-a4a4-9168-2602140548d7"> </a><p><b>Generated Narrative: Substance</b><a name="ef17cff1-6586-a4a4-9168-2602140548d7"> </a><a name="hcef17cff1-6586-a4a4-9168-2602140548d7"> </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 Substance &quot;ef17cff1-6586-a4a4-9168-2602140548d7&quot; </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2020-03</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 120 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Production <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C133990 &quot;Commercial&quot;)</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: See on this page: Organization/3d399cbc-244e-9b5f-838b-b7daa0489330</p></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>: CAT3</p><p><b>instance</b>: true</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>See on this page: SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130</td></tr></table></div>
        </text>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch">
          <extension url="manufacturingDate">
            <valueDateTime value="2020-03"/>
          </extension>
          <extension url="batchQuantity">
            <valueQuantity>
              <value value="120"/>
              <unit value="kg"/>
            </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>
              <!-- Organization/substance-manufacturer -->
              <reference
                         value="Organization/3d399cbc-244e-9b5f-838b-b7daa0489330"/>
            </valueReference>
          </extension>
        </extension>
        <!--  local extensions  -->
        <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="CAT3"/>
        </identifier>
        <instance value="true"/>
        <code>
          <reference>
            <!-- SubstanceDefinition/substance1 -->
            <reference
                       value="SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130"/>
          </reference>
        </code>
      </Substance>
    </resource>
  </entry>
</Bundle>