Pharmaceutical Quality (Industry)
1.0.0 - STU1
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
<Bundle xmlns="http://hl7.org/fhir">
<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>
<language value="en"/>
<type value="collection"/>
<entry>
<fullUrl value="urn:uuid:1d1d1d1d-1d1d-1d1d-1d1d-1d1d1d1d1d1d"/>
<resource>
<MedicinalProductDefinition>
<id value="medicinalproductdefinition-drug-product-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_medicinalproductdefinition-drug-product-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition medicinalproductdefinition-drug-product-pq-ex1</b></p><a name="medicinalproductdefinition-drug-product-pq-ex1"> </a><a name="hcmedicinalproductdefinition-drug-product-pq-ex1"> </a><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"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-MedicinalProductDefinition-drug-product-pq.html">MedicinalProductDefinition - Drug Product PQ</a></p></div><p><b>identifier</b>: <code>http://example.org/identifiers/product</code>/PROD-12345</p><p><b>combinedPharmaceuticalDoseForm</b>: <span title="Codes:{http://standardterms.edqm.eu 10219000}">Tablet</span></p><p><b>route</b>: <span title="Codes:{http://standardterms.edqm.eu 20053000}">Oral use</span></p><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ProductName</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>Stelbatolol 10mg Tablets</td><td><span title="Codes:{http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-product-name-type-pq INV}">Invented Name</span></td></tr></table></div>
</text>
<identifier>
<system value="http://example.org/identifiers/product"/>
<value value="PROD-12345"/>
</identifier>
<combinedPharmaceuticalDoseForm>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="10219000"/>
<display value="Tablet"/>
</coding>
</combinedPharmaceuticalDoseForm>
<route>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="20053000"/>
<display value="Oral use"/>
</coding>
</route>
<name>
<productName value="Stelbatolol 10mg Tablets"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-product-name-type-pq"/>
<code value="INV"/>
<display value="Invented Name"/>
</coding>
</type>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:2d2d2d2d-2d2d-2d2d-2d2d-2d2d2d2d2d2d"/>
<resource>
<Medication>
<id value="medication-batch-information-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Medication-batch-information-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Medication_medication-batch-information-drug-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: Medication medication-batch-information-drug-pq-ex1</b></p><a name="medication-batch-information-drug-pq-ex1"> </a><a name="hcmedication-batch-information-drug-pq-ex1"> </a><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"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Medication-batch-information-drug-pq.html">Medication - Batch Information Drug PQ</a></p></div><p><b>code</b>: <span title="Codes:"></span></p><blockquote><p><b>batch</b></p><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p>manufacturingDate</blockquote><p><b>value</b>: 2020-06</p><blockquote><p><b>url</b></p>batchQuantity</blockquote><p><b>value</b>: 100100 tablets</p><blockquote><p><b>url</b></p>batchUtilization</blockquote><p><b>value</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C133990}">Production</span></p><blockquote><p><b>url</b></p>assignedManufacturer</blockquote><p><b>value</b>: <a href="Organization-organization-drug-pq-ex1.html">Organization AAA Molybdenum Products, Inc.</a></p><p><b>closureSystemDescription</b>: 100 cc HDPE Bottle 2 g desiccant</p><blockquote><p><b>url</b></p>container</blockquote></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Designation PQ</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/batch-designation maximum}">Maximum</span></p><p><b>Extension - Batch Number of Vials PQ</b>: 3</p><p><b>Extension - Batch Substance Batch PQ</b>: <a href="Substance-substance-drug-pq-ex1.html">Substance </a></p><p><b>Extension - Packaging Date PQ</b>: 2020-08</p><p><b>Extension - Packaging Site PQ</b>: <a href="Organization-organization-drug-pq-ex1.html">Organization AAA Molybdenum Products, Inc.</a></p><p><b>Extension - Actual Yield PQ</b>: 4.81 kg</p><p><b>Extension - Actual Yield Unfiltered PQ</b>: 4.91 kg</p><p><b>Extension Target Fill Weight PQ</b>: 30 g</p><p><b>lotNumber</b>: 33445</p></blockquote></div>
</text>
<code>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq">
<valueReference>🔗
<reference
value="MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"/>
</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="C133990"/>
<display value="Commercial"/>
</coding>
<text value="Production"/>
</valueCodeableConcept>
</extension>
<extension url="assignedManufacturer">
<valueReference>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</valueReference>
</extension>
<extension url="container">
<extension url="closureSystemDescription">
<valueString value="100 cc HDPE Bottle 2 g desiccant"/>
</extension>
</extension>
</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-batch-designation-pq">
<valueCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/batch-designation"/>
<code value="maximum"/>
<display value="Maximum"/>
</coding>
<text value="Maximum"/>
</valueCodeableConcept>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-number-of-vials-pq">
<valuePositiveInt value="3"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-substance-batch-pq">
<valueReference>🔗
<reference value="Substance/substance-drug-pq-ex1"/>
</valueReference>
</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>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</valueReference>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq">
<valueQuantity>
<value value="4.81"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-unfiltered-pq">
<valueQuantity>
<value value="4.91"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-target-fill-weight-pq">
<valueQuantity>
<value value="30"/>
<unit value="g"/>
</valueQuantity>
</extension>
<lotNumber value="33445"/>
</batch>
</Medication>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:3d3d3d3d-3d3d-3d3d-3d3d-3d3d3d3d3d3d"/>
<resource>
<Organization>
<id value="organization-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_organization-drug-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: Organization organization-drug-pq-ex1</b></p><a name="organization-drug-pq-ex1"> </a><a name="hcorganization-drug-pq-ex1"> </a><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"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Organization-drug-pq.html">Organization - Drug PQ</a></p></div><p><b>identifier</b>: <a href="http://terminology.hl7.org/7.1.0/NamingSystem-FEI.html" title=""A FDA Establishment Identifier or Firm Establishment Identifier (FEI) is an FDA system generated number used to identify a firm. FDA systems interact, occasionally creating multiple records (FEIs) for one firm. Upon evaluation, these numbers are merged into one surviving FEI which is used to identify the firm. The remaining FEIs become children of the surviving FEI and are not used to identify the firm."
For more information, see [https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=common.faq](https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=common.faq).">FDA Establishment Identifier</a>/3003040516</p><p><b>active</b>: true</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type drug-substance-manufacture}">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>
<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>
</Bundle>
IG © 2023+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0.
Generated
2026-05-10
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