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 - TTL Representation

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    @prefix fhir: <http://hl7.org/fhir/> .
    @prefix owl: <http://www.w3.org/2002/07/owl#> .
    @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
    @prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

    # - resource -------------------------------------------------------------------

    #  Substance Batch Info

     a fhir:Bundle ;
      fhir:nodeRole fhir:treeRoot ;
      fhir:id [ fhir:v "bundle-drug-substance-batch-info-pq-ex1"] ; # id value="substance-batch-analysis"/
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-batch-info-pq"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-batch-info-pq>     ] )
      ] ; #
      fhir:type [ fhir:v "collection"] ; #
      fhir:entry ( [
    fhir:fullUrl [ fhir:v "urn:uuid:8dae93e0-048d-35a4-71ea-7c603184a130"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:8dae93e0-048d-35a4-71ea-7c603184a130> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:3d399cbc-244e-9b5f-838b-b7daa0489330"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:3d399cbc-244e-9b5f-838b-b7daa0489330> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:87ef899b-14dd-26b7-7416-7ec1d01b62a1"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:87ef899b-14dd-26b7-7416-7ec1d01b62a1> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:6412c5d4-1b7d-8405-85dc-75dbaa300ea4"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:6412c5d4-1b7d-8405-85dc-75dbaa300ea4> )
      ] [
    fhir:fullUrl [ fhir:v "urn:uuid:ef17cff1-6586-a4a4-9168-2602140548d7"^^xsd:anyURI ] ;
        ( fhir:resource <urn:uuid:ef17cff1-6586-a4a4-9168-2602140548d7> )
      ] ) . #

    <urn:uuid:8dae93e0-048d-35a4-71ea-7c603184a130> a fhir:SubstanceDefinition ;
      fhir:id [ fhir:v "8dae93e0-048d-35a4-71ea-7c603184a130"] ; # substance1
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<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>"
      ] ; #
      fhir:manufacturer ( [
    fhir:reference [ fhir:v "Organization/3d399cbc-244e-9b5f-838b-b7daa0489330" ] # Organization\/substance-manufacturer
      ] ) ; #
      fhir:name ( [
    fhir:name [ fhir:v "Stelbatolol" ]
      ] ) . #

    <urn:uuid:3d399cbc-244e-9b5f-838b-b7daa0489330> a fhir:Organization ;
      fhir:id [ fhir:v "3d399cbc-244e-9b5f-838b-b7daa0489330"] ; # substance-manufacturer
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<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>"
      ] ; #
      fhir:identifier ( [
    fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.4.82"^^xsd:anyURI ] ; #  FDA establishment identifier
    fhir:value [ fhir:v "3003040516" ]
      ] ) ; #
      fhir:active [ fhir:v "true"^^xsd:boolean] ; #
      fhir:type ( [
        ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "drug-substance-manufacture" ] ;
    fhir:display [ fhir:v "Drug Substance Manufacture" ]     ] )
      ] ) ; #
      fhir:name [ fhir:v "AAA Molybdenum Products, Inc."] ; #
      fhir:contact ( [
    fhir:address [
          ( fhir:line [ fhir:v "7233 W 116th Pl" ] [ fhir:v "Ste C" ] ) ;
    fhir:city [ fhir:v "Broomfield" ] ;
    fhir:state [ fhir:v "Colorado" ] ;
    fhir:postalCode [ fhir:v "80020" ] ;
    fhir:country [ fhir:v "USA" ]     ]
      ] ) . #

    <urn:uuid:87ef899b-14dd-26b7-7416-7ec1d01b62a1> a fhir:Substance ;
      fhir:id [ fhir:v "87ef899b-14dd-26b7-7416-7ec1d01b62a1"] ; # substance-dxpq-ex1
      fhir:text [
    fhir:status [ fhir:v "extensions" ] ;
    fhir:div "<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>"
      ] ; #
      fhir:extension ( [
    fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch"^^xsd:anyURI ] ;
        ( fhir:extension [
    fhir:url [ fhir:v "manufacturingDate"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "2020-01"^^xsd:gYearMonth ]     ] [
    fhir:url [ fhir:v "batchQuantity"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Quantity ;
    fhir:value [ fhir:v "120"^^xsd:decimal ] ;
    fhir:unit [ fhir:v "kg" ]       ]     ] [
    fhir:url [ fhir:v "batchUtilization"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:CodeableConcept ;
            ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C133990" ] ;
    fhir:display [ fhir:v "Commercial" ]         ] ) ;
    fhir:text [ fhir:v "Production" ]       ]     ] [
    fhir:url [ fhir:v "assignedManufacturer"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Reference ;
    fhir:reference [ fhir:v "Organization/3d399cbc-244e-9b5f-838b-b7daa0489330" ] # Organization\/substance-manufacturer       ]     ] )
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "2019-09-08"^^xsd:date ]
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "2022-09-08"^^xsd:date ]
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-process-pq"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Reference ;
    fhir:display [ fhir:v "Process 1.1" ]     ]
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Quantity ;
    fhir:value [ fhir:v "4.8"^^xsd:decimal ] ;
    fhir:unit [ fhir:v "kg" ]     ]
      ] ) ; #  was actual-batch-substance
      fhir:identifier ( [
    fhir:value [ fhir:v "CAT1" ]
      ] ) ; #
      fhir:instance [ fhir:v "true"^^xsd:boolean] ; #
      fhir:code [
    fhir:reference [
    fhir:reference [ fhir:v "SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130" ] # SubstanceDefinition\/substance1     ]
      ] . #

    <urn:uuid:6412c5d4-1b7d-8405-85dc-75dbaa300ea4> a fhir:Substance ;
      fhir:id [ fhir:v "6412c5d4-1b7d-8405-85dc-75dbaa300ea4"] ; # actual-batch-substance-2
      fhir:text [
    fhir:status [ fhir:v "extensions" ] ;
    fhir:div "<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>"
      ] ; #
      fhir:extension ( [
    fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch"^^xsd:anyURI ] ;
        ( fhir:extension [
    fhir:url [ fhir:v "manufacturingDate"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "2020-02"^^xsd:gYearMonth ]     ] [
    fhir:url [ fhir:v "batchQuantity"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Quantity ;
    fhir:value [ fhir:v "120"^^xsd:decimal ] ;
    fhir:unit [ fhir:v "kg" ]       ]     ] [
    fhir:url [ fhir:v "batchUtilization"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:CodeableConcept ;
            ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C133990" ] ;
    fhir:display [ fhir:v "Commercial" ]         ] ) ;
    fhir:text [ fhir:v "Production" ]       ]     ] [
    fhir:url [ fhir:v "assignedManufacturer"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Reference ;
    fhir:reference [ fhir:v "Organization/3d399cbc-244e-9b5f-838b-b7daa0489330" ] # Organization\/substance-manufacturer       ]     ] )
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "2019-09-08"^^xsd:date ]
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "2022-09-08"^^xsd:date ]
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Quantity ;
    fhir:value [ fhir:v "4.8"^^xsd:decimal ] ;
    fhir:unit [ fhir:v "kg" ]     ]
      ] ) ; #
      fhir:identifier ( [
    fhir:value [ fhir:v "CAT2" ]
      ] ) ; #
      fhir:instance [ fhir:v "true"^^xsd:boolean] ; #
      fhir:code [
    fhir:reference [
    fhir:reference [ fhir:v "SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130" ] # SubstanceDefinition\/substance1     ]
      ] . #

    <urn:uuid:ef17cff1-6586-a4a4-9168-2602140548d7> a fhir:Substance ;
      fhir:id [ fhir:v "ef17cff1-6586-a4a4-9168-2602140548d7"] ; # actual-batch-substance-3
      fhir:text [
    fhir:status [ fhir:v "extensions" ] ;
    fhir:div "<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>"
      ] ; #
      fhir:extension ( [
    fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch"^^xsd:anyURI ] ;
        ( fhir:extension [
    fhir:url [ fhir:v "manufacturingDate"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "2020-03"^^xsd:gYearMonth ]     ] [
    fhir:url [ fhir:v "batchQuantity"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Quantity ;
    fhir:value [ fhir:v "120"^^xsd:decimal ] ;
    fhir:unit [ fhir:v "kg" ]       ]     ] [
    fhir:url [ fhir:v "batchUtilization"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:CodeableConcept ;
            ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C133990" ] ;
    fhir:display [ fhir:v "Commercial" ]         ] ) ;
    fhir:text [ fhir:v "Production" ]       ]     ] [
    fhir:url [ fhir:v "assignedManufacturer"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Reference ;
    fhir:reference [ fhir:v "Organization/3d399cbc-244e-9b5f-838b-b7daa0489330" ] # Organization\/substance-manufacturer       ]     ] )
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "2019-09-08"^^xsd:date ]
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "2022-09-08"^^xsd:date ]
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Quantity ;
    fhir:value [ fhir:v "4.8"^^xsd:decimal ] ;
    fhir:unit [ fhir:v "kg" ]     ]
      ] ) ; #
      fhir:identifier ( [
    fhir:value [ fhir:v "CAT3" ]
      ] ) ; #
      fhir:instance [ fhir:v "true"^^xsd:boolean] ; #
      fhir:code [
    fhir:reference [
    fhir:reference [ fhir:v "SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130" ] # SubstanceDefinition\/substance1     ]
      ] . #