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-product-impurities-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-impurities-pq"/>
</meta>
<language value="en"/>
<type value="collection"/>
<entry>
<fullUrl value="urn:uuid:1g1g1g1g-1g1g-1g1g-1g1g-1g1g1g1g1g1g"/>
<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:2g2g2g2g-2g2g-2g2g-2g2g-2g2g2g2g2g2g"/>
<resource>
<SubstanceDefinition>
<id value="substancedefinition-component-substance-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_substancedefinition-component-substance-drug-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition substancedefinition-component-substance-drug-pq-ex1</b></p><a name="substancedefinition-component-substance-drug-pq-ex1"> </a><a name="hcsubstancedefinition-component-substance-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-SubstanceDefinition-component-substance-drug-pq.html">SubstanceDefinition - Component Substance Drug PQ</a></p></div><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>manufacturer</b>: <a href="Organization-organization-drug-pq-ex1.html">Organization AAA Molybdenum Products, Inc.</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 Hydrochloride</td></tr></table></div>
</text>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<manufacturer>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</manufacturer>
<name>
<name value="Stelbatolol Hydrochloride"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:3g3g3g3g-3g3g-3g3g-3g3g-3g3g3g3g3g3g"/>
<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:4g4g4g4g-4g4g-4g4g-4g4g-4g4g4g4g4g4g"/>
<resource>
<DiagnosticReport>
<id value="diagnosticreport-analysis-drug-pq-stability-prod"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="DiagnosticReport_diagnosticreport-analysis-drug-pq-stability-prod"> </a><p class="res-header-id"><b>Generated Narrative: DiagnosticReport diagnosticreport-analysis-drug-pq-stability-prod</b></p><a name="diagnosticreport-analysis-drug-pq-stability-prod"> </a><a name="hcdiagnosticreport-analysis-drug-pq-stability-prod"> </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-DiagnosticReport-analysis-drug-pq.html">DiagnosticReport - Analysis Drug PQ</a></p></div><h2><span title="Codes:{http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type Stability Study Report - 18 months}">Stability Study Report - 18 months</span> </h2><table class="grid"><tr><td>When For</td><td>2020-12</td></tr><tr><td>Performer</td><td> <a href="Organization-organization-drug-pq-ex1.html">Organization AAA Molybdenum Products, Inc.</a></td></tr><tr><td>Identifier</td><td> <code>https://eudract.europa.eu/example/identifier</code>/ABC1234</td></tr></table><p><b>Report Details</b></p><table class="grid"><tr><td><b>Code</b></td><td><b>Value</b></td><td><b>Flags</b></td><td><b>When For</b></td></tr><tr><td><a href="Observation-observation-test-result-longterm25c-initial-1.html"><span title="Codes:">Test Components - Long-term 25C etc - Initial (XYZ)</span></a></td><td/><td>Final</td><td>2023-01-01 12:00:00+0000</td></tr></table><div><p>The samples have been assessed for initial period; no shelf life determined.</p>
</div></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>🔗
<reference
value="PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol"/>
</valueReference>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq">
<valueCodeableConcept>
<text
value="information about statistical model utilized to interpret stability study results"/>
</valueCodeableConcept>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq">
<valueCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/container-orientation"/>
<code value="horizontal"/>
<display value="horizontal"/>
</coding>
<text value="Horizontal"/>
</valueCodeableConcept>
</extension>
<identifier>
<system value="https://eudract.europa.eu/example/identifier"/>
<value value="ABC1234"/>
</identifier>
<status value="final"/>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type"/>
<code value="Stability Study Report - 18 months"/>
<display value="Stability Study Report - 18 months"/>
</coding>
</code>
<effectiveDateTime value="2020-12">
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq">
<valueCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/time-point-description"/>
<code value="Delayed Start Code"/>
<display value="Delayed Start Code"/>
</coding>
<text value="Refrigerated delayed testing"/>
</valueCodeableConcept>
</extension>
</effectiveDateTime>
<performer>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</performer>
<result>🔗
<reference
value="Observation/observation-test-result-longterm25c-initial-1"/>
</result>
<conclusion
value="The samples have been assessed for initial period; no shelf life determined."/>
</DiagnosticReport>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:5g5g5g5g-5g5g-5g5g-5g5g-5g5g5g5g5g5g"/>
<resource>
<Observation>
<id value="observation-test-result-lt25c-i1-degradation-imp-total"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Observation_observation-test-result-lt25c-i1-degradation-imp-total"> </a><p class="res-header-id"><b>Generated Narrative: Observation observation-test-result-lt25c-i1-degradation-imp-total</b></p><a name="observation-test-result-lt25c-i1-degradation-imp-total"> </a><a name="hcobservation-test-result-lt25c-i1-degradation-imp-total"> </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-Observation-test-result-drug-pq.html">Observation - Test Result Drug PQ</a></p></div><p><b>status</b>: Final</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example DGP}">Degradation Products</span></p><p><b>subject</b>: <a href="Medication-medication-batch-information-drug-pq-ex1.html">Medication </a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Organization-organization-drug-pq-ex1.html">Organization AAA Molybdenum Products, Inc.</a></p><p><b>value</b>: 0.801 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code% = '%')</span></p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example IMP}">Impurity</span></td><td><span title="Codes:">Total Degradation Impurities</span></td></tr></table></div>
</text>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>🔗
<reference
value="Medication/medication-batch-information-drug-pq-ex1"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</performer>
<valueQuantity>
<value value="0.801"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Total Degradation Impurities"/>
</valueCodeableConcept>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:6g6g6g6g-6g6g-6g6g-6g6g-6g6g6g6g6g6g"/>
<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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