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

## : 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>