Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
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
<!-- 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"><p><b>Generated Narrative: SubstanceDefinition</b><a name="8dae93e0-048d-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 "8dae93e0-048d-35a4-71ea-7c603184a130" </p></div><p><b>manufacturer</b>: <a href="#Organization_3d399cbc-244e-9b5f-838b-b7daa0489330">See above (Organization/3d399cbc-244e-9b5f-838b-b7daa0489330)</a></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"><p><b>Generated Narrative: Organization</b><a name="3d399cbc-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 "3d399cbc-244e-9b5f-838b-b7daa0489330" </p></div><p><b>identifier</b>: id: 3003040516</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>
<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"><p><b>Generated Narrative: Substance</b><a name="87ef899b-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 "87ef899b-14dd-26b7-7416-7ec1d01b62a1" </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 "Commercial")</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href="#Organization_3d399cbc-244e-9b5f-838b-b7daa0489330">See above (Organization/3d399cbc-244e-9b5f-838b-b7daa0489330)</a></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>: id: 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><a href="#SubstanceDefinition_8dae93e0-048d-35a4-71ea-7c603184a130">See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)</a></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"><p><b>Generated Narrative: Substance</b><a name="6412c5d4-1b7d-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 "6412c5d4-1b7d-8405-85dc-75dbaa300ea4" </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 "Commercial")</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href="#Organization_3d399cbc-244e-9b5f-838b-b7daa0489330">See above (Organization/3d399cbc-244e-9b5f-838b-b7daa0489330)</a></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>: id: 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><a href="#SubstanceDefinition_8dae93e0-048d-35a4-71ea-7c603184a130">See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)</a></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"><p><b>Generated Narrative: Substance</b><a name="ef17cff1-6586-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 "ef17cff1-6586-a4a4-9168-2602140548d7" </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 "Commercial")</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href="#Organization_3d399cbc-244e-9b5f-838b-b7daa0489330">See above (Organization/3d399cbc-244e-9b5f-838b-b7daa0489330)</a></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>: id: 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><a href="#SubstanceDefinition_8dae93e0-048d-35a4-71ea-7c603184a130">See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)</a></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>
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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