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 – Product Batch Information - XML Representation

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<Bundle xmlns="http://hl7.org/fhir">
  <!--  Product Batch Info  -->
  <id value="bundle-drug-product-batch-info-pq-ex1"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-batch-info-pq"/>
  </meta>
  <type value="collection"/>
  <!--  Section 8 - Batch or Lot Information (batch 1 of 3)  -->
  <entry>
    <fullUrl value="urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
    <resource>
      <Medication>
        <!-- medication-actual-batch -->
        <id value="339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"> </a><p><b>Generated Narrative: Medication</b><a name="339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"> </a><a name="hc339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"> </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 Medication &quot;339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51&quot; </p></div><p><b>code</b>:  <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>Batches</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style="display: none">*</td><td>, , , , </td><td>33445</td></tr></table></div>
        </text>
        <code>
          <extension
                     url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq">
            <valueReference>
              <!--  todo consider change this be the MID?  -->
              <!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1 -->
              <reference
                         value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
            </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="C185328"/>
                  <display value="Stability Study"/>
                </coding>
                <text value="PPQ / Stability"/>
              </valueCodeableConcept>
            </extension>
            <extension url="assignedManufacturer">
              <valueReference>
                <!-- Organization/manufacturer -->
                <reference
                           value="Organization/0102bca4-46c1-a6bf-1025-cd403fee710a"/>
              </valueReference>
            </extension>
            <extension url="container">
              <extension url="closureSystemDescription">
                <valueString value="100 cc HDPE Bottle 2 g desiccant"/>
              </extension>
            </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-actual-yield-pq">
            <valueQuantity>
              <value value="4.8"/>
              <unit value="kg"/>
            </valueQuantity>
          </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>
              <!-- Organization/packaging -->
              <reference
                         value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b07"/>
            </valueReference>
          </extension>
          <lotNumber value="33445"/>
        </batch>
      </Medication>
    </resource>
  </entry>
  <!--  Section 8 - Batch or Lot Information (another batch 2 of 3)  -->
  <entry>
    <fullUrl value="urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
    <resource>
      <Medication>
        <!-- medication-actual-batch-2 -->
        <id value="a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc"> </a><p><b>Generated Narrative: Medication</b><a name="a9dfda53-734b-045f-7ae4-94a6281d53bc"> </a><a name="hca9dfda53-734b-045f-7ae4-94a6281d53bc"> </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 Medication &quot;a9dfda53-734b-045f-7ae4-94a6281d53bc&quot; </p></div><p><b>code</b>:  <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>Batches</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style="display: none">*</td><td>, , , , </td><td>33446</td></tr></table></div>
        </text>
        <code>
          <extension
                     url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq">
            <valueReference>
              <!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1 -->
              <reference
                         value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
            </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="100050"/>
                <unit value="tablets"/>
              </valueQuantity>
            </extension>
            <extension url="batchUtilization">
              <valueCodeableConcept>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C185328"/>
                  <display value="Stability Study"/>
                </coding>
                <text value="PPQ / Stability"/>
              </valueCodeableConcept>
            </extension>
            <extension url="assignedManufacturer">
              <valueReference>
                <!-- Organization/manufacturer -->
                <reference
                           value="Organization/0102bca4-46c1-a6bf-1025-cd403fee710a"/>
              </valueReference>
            </extension>
            <extension url="container">
              <extension url="closureSystemDescription">
                <valueString value="100 cc HDPE Bottle 2 g desiccant"/>
              </extension>
            </extension>
          </extension>
          <!--  local extensions  -->
          <extension
                     url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq">
            <valueQuantity>
              <value value="4.8"/>
              <unit value="kg"/>
            </valueQuantity>
          </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-packaging-date-pq">
            <valueDateTime value="2020-08"/>
          </extension>
          <extension
                     url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq">
            <valueReference>
              <!-- Organization/packaging -->
              <reference
                         value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b07"/>
            </valueReference>
          </extension>
          <lotNumber value="33446"/>
        </batch>
      </Medication>
    </resource>
  </entry>
  <!--  Section 8 - Batch or Lot Information (another batch 3 of 3)  -->
  <entry>
    <fullUrl value="urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
    <resource>
      <Medication>
        <!-- medication-actual-batch-3 -->
        <id value="c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06"> </a><p><b>Generated Narrative: Medication</b><a name="c6f5fadd-62e6-3a01-93d9-b3b182f67d06"> </a><a name="hcc6f5fadd-62e6-3a01-93d9-b3b182f67d06"> </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 Medication &quot;c6f5fadd-62e6-3a01-93d9-b3b182f67d06&quot; </p></div><p><b>code</b>:  <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>Batches</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style="display: none">*</td><td>, , , , </td><td>33447</td></tr></table></div>
        </text>
        <code>
          <extension
                     url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq">
            <valueReference>
              <!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1 -->
              <reference
                         value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
            </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="100125"/>
                <unit value="tablets"/>
              </valueQuantity>
            </extension>
            <extension url="batchUtilization">
              <valueCodeableConcept>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C185328"/>
                  <display value="Stability Study"/>
                </coding>
                <text value="PPQ / Stability"/>
              </valueCodeableConcept>
            </extension>
            <extension url="assignedManufacturer">
              <valueReference>
                <!-- Organization/manufacturer -->
                <reference
                           value="Organization/0102bca4-46c1-a6bf-1025-cd403fee710a"/>
              </valueReference>
            </extension>
            <extension url="container">
              <extension url="closureSystemDescription">
                <valueString value="100 cc HDPE Bottle 2 g desiccant"/>
              </extension>
            </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-packaging-date-pq">
            <valueDateTime value="2020-08"/>
          </extension>
          <extension
                     url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq">
            <valueReference>
              <!-- Organization/packaging -->
              <reference
                         value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b07"/>
            </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>
          <lotNumber value="33447"/>
        </batch>
      </Medication>
    </resource>
  </entry>
  <!--  Section 4.1 - Manufacturer  -->
  <entry>
    <fullUrl value="urn:uuid:0102bca4-46c1-a6bf-1025-cd403fee710a"/>
    <resource>
      <Organization>
        <!-- manufacturer -->
        <id value="0102bca4-46c1-a6bf-1025-cd403fee710a"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_0102bca4-46c1-a6bf-1025-cd403fee710a"> </a><p><b>Generated Narrative: Organization</b><a name="0102bca4-46c1-a6bf-1025-cd403fee710a"> </a><a name="hc0102bca4-46c1-a6bf-1025-cd403fee710a"> </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;0102bca4-46c1-a6bf-1025-cd403fee710a&quot; </p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.4.82</code>/3010027650</p><p><b>active</b>: true</p><p><b>type</b>: Drug Product Manufacture <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-organization-type.html">Pharmaceutical Organization Type Codes</a>#drug-product-manufacture)</span></p><p><b>name</b>: AAA Pharmaceutical, 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>681 Main Street Lumberton New Jersey 08048 USA </td></tr></table></div>
        </text>
        <identifier>
          <!--  FDA establishment identifier  -->
          <system value="urn:oid:2.16.840.1.113883.4.82"/>
          <value value="3010027650"/>
        </identifier>
        <active value="true"/>
        <type>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type"/>
            <code value="drug-product-manufacture"/>
            <display value="Drug Product Manufacture"/>
          </coding>
        </type>
        <name value="AAA Pharmaceutical, Inc."/>
        <contact>
          <address>
            <line value="681 Main Street"/>
            <city value="Lumberton"/>
            <state value="New Jersey"/>
            <postalCode value="08048"/>
            <country value="USA"/>
          </address>
        </contact>
      </Organization>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b07"/>
    <resource>
      <Organization>
        <!-- packaging -->
        <id value="378fbe5f-5926-3a5c-4c64-5428df877b07"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_378fbe5f-5926-3a5c-4c64-5428df877b07"> </a><p><b>Generated Narrative: Organization</b><a name="378fbe5f-5926-3a5c-4c64-5428df877b07"> </a><a name="hc378fbe5f-5926-3a5c-4c64-5428df877b07"> </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;378fbe5f-5926-3a5c-4c64-5428df877b07&quot; </p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.4.82</code>/3008816891</p><p><b>active</b>: true</p><p><b>type</b>: Packaging <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-organization-type.html">Pharmaceutical Organization Type Codes</a>#packaging)</span></p><p><b>name</b>: MySite</p></div>
        </text>
        <identifier>
          <system value="urn:oid:2.16.840.1.113883.4.82"/>
          <value value="3008816891"/>
        </identifier>
        <active value="true"/>
        <type>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type"/>
            <code value="packaging"/>
            <display value="Packaging"/>
          </coding>
        </type>
        <name value="MySite"/>
      </Organization>
    </resource>
  </entry>
  <!--  MedicinalProductDefinition - the main resource in any product scenario  -->
  <entry>
    <fullUrl value="urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
    <!--  Section 1.1 - DP Identification  -->
    <resource>
      <MedicinalProductDefinition>
        <!-- medicinalproductdefinition-drug-product-dxpq-ex1 -->
        <id value="a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"> </a><p><b>Generated Narrative: MedicinalProductDefinition</b><a name="a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"> </a><a name="hca0694a7a-aafa-4cbe-8135-c788a9a4d3d5"> </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 MedicinalProductDefinition &quot;a0694a7a-aafa-4cbe-8135-c788a9a4d3d5&quot; </p></div><p><b>description</b>: Textual description of the product</p><p><b>combinedPharmaceuticalDoseForm</b>: Gastro-resistant tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (standardterms.edqm.eu#10225000)</span></p><p><b>route</b>: Oral use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (standardterms.edqm.eu#20053000)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Stelbat Tablets, 20mg</p><p><b>type</b>: Proprietary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-productNameType-pq-example.html">Product Name Type - example</a>#Proprietary)</span></p><h3>Parts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Part</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>20mg</td><td>Strength part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-medicinal-product-name-part-type.html">Product Name Part Type</a>#StrengthPart)</span></td></tr></table></blockquote></div>
        </text>
        <description value="Textual description of the product"/>
        <combinedPharmaceuticalDoseForm>
          <coding>
            <system value="http://standardterms.edqm.eu"/>
            <code value="10225000"/>
            <display value="Gastro-resistant tablet"/>
          </coding>
        </combinedPharmaceuticalDoseForm>
        <route>
          <coding>
            <system value="http://standardterms.edqm.eu"/>
            <code value="20053000"/>
            <display value="Oral use"/>
          </coding>
        </route>
        <name>
          <productName value="Stelbat Tablets, 20mg"/>
          <type>
            <coding>
              <system
                      value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-pq-example"/>
              <code value="Proprietary"/>
              <display value="Proprietary"/>
            </coding>
          </type>
          <part>
            <part value="20mg"/>
            <type>
              <coding>
                <system
                        value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
                <code value="StrengthPart"/>
                <display value="Strength part"/>
              </coding>
            </type>
          </part>
        </name>
      </MedicinalProductDefinition>
    </resource>
  </entry>
</Bundle>