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-stability-pq-ex2-sub"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-stability-pq"/>
</meta>
<language value="en"/>
<type value="collection"/>
<entry>
<fullUrl
value="http://example.com/SubstanceDefinition/substance-drug-pq-ex1"/>
<resource>
<Substance>
<id value="substance-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Substance_substance-drug-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: Substance substance-drug-pq-ex1</b></p><a name="substance-drug-pq-ex1"> </a><a name="hcsubstance-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-Substance-drug-pq.html">Substance - Drug PQ</a></p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><ul><li>manufacturingDate: 2019-09-07</li><li>batchQuantity: 5 kg</li><li>batchUtilization: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C133991}">Development</span></li><li>assignedManufacturer: <a href="Organization-organization-drug-pq-ex1.html">Organization AAA Molybdenum Products, Inc.</a></li></ul></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>: CAT1</p><p><b>instance</b>: false</p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Substance</span></td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch">
<extension url="manufacturingDate">
<valueDateTime value="2019-09-07"/>
</extension>
<extension url="batchQuantity">
<valueQuantity>
<value value="5"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension url="batchUtilization">
<valueCodeableConcept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C133991"/>
<display value="Development"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="assignedManufacturer">
<valueReference>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</valueReference>
</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-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="CAT1"/>
</identifier>
<instance value="false"/>
<code>
<concept>
<text value="Substance"/>
</concept>
</code>
</Substance>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.com/SpecimenDefinition/specimendefinition-drug-pq-ex1"/>
<resource>
<SpecimenDefinition>
<id value="specimendefinition-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SpecimenDefinition_specimendefinition-drug-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: SpecimenDefinition specimendefinition-drug-pq-ex1</b></p><a name="specimendefinition-drug-pq-ex1"> </a><a name="hcspecimendefinition-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-SpecimenDefinition-drug-pq.html">SpecimenDefinition - Drug PQ</a></p></div><p><b>status</b>: Active</p><blockquote><p><b>typeTested</b></p><p><b>preference</b>: Preferred</p><h3>Handlings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Instruction</b></td></tr><tr><td style="display: none">*</td><td><div><p>25°C/60% RH</p>
</div></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<typeTested>
<preference value="preferred"/>
<handling>
<instruction value="25°C/60% RH"/>
</handling>
</typeTested>
</SpecimenDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.com/Substance/substance-drug-pq-ex1"/>
<resource>
<Substance>
<id value="substance-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Substance_substance-drug-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: Substance substance-drug-pq-ex1</b></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"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Substance-drug-pq.html">Substance - Drug PQ</a></p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><ul><li>manufacturingDate: 2019-09-07</li><li>batchQuantity: 5 kg</li><li>batchUtilization: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C133991}">Development</span></li><li>assignedManufacturer: <a href="Organization-organization-drug-pq-ex1.html">Organization AAA Molybdenum Products, Inc.</a></li></ul></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>: CAT1</p><p><b>instance</b>: false</p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Substance</span></td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch">
<extension url="manufacturingDate">
<valueDateTime value="2019-09-07"/>
</extension>
<extension url="batchQuantity">
<valueQuantity>
<value value="5"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension url="batchUtilization">
<valueCodeableConcept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C133991"/>
<display value="Development"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="assignedManufacturer">
<valueReference>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</valueReference>
</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-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="CAT1"/>
</identifier>
<instance value="false"/>
<code>
<concept>
<text value="Substance"/>
</concept>
</code>
</Substance>
</resource>
</entry>
<entry>
<fullUrl value="http://example.com/Specimen/specimen-drug-pq-ex1"/>
<resource>
<Specimen>
<id value="specimen-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Specimen_specimen-drug-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: Specimen specimen-drug-pq-ex1</b></p><a name="specimen-drug-pq-ex1"> </a><a name="hcspecimen-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-Specimen-drug-pq.html">Specimen - Drug PQ</a></p></div><h3>Collections</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Collected[x]</b></td></tr><tr><td style="display: none">*</td><td>2020-12-01</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: No storage</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 25°C/60% RH</p></blockquote></div>
</text>
<collection>
<collectedDateTime value="2020-12-01"/>
</collection>
<processing>
<description value="No storage"/>
</processing>
<processing>
<description value="25°C/60% RH"/>
</processing>
</Specimen>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.com/PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol"/>
<resource>
<PlanDefinition>
<id value="plandefinition-drug-pq-ex5-stability-study-protocol"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PlanDefinition_plandefinition-drug-pq-ex5-stability-study-protocol"> </a>
<table class="narrative-table">
<tbody>
<tr>
<th colspan="2" scope="row" class="row-header">Metadata</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Stability Monitoring Program</td>
</tr>
<tr>
<th scope="row" class="row-header">Subject Type</th>
<td class="content-container"><a href="MedicinalProductDefinition-medicinalproductdefinition-drug-product-pq-ex1.html">MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use</a></td>
</tr>
<tr>
<th scope="row" class="row-header">Description</th>
<td class="content-container"><div><p>Narrative description of Stability Study</p>
</div></td>
</tr>
<tr>
<th scope="row" class="row-header">Type</th>
<td class="content-container">
Stability Study Protocol
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Action</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg)</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Long-Term</td>
</tr>
<tr>
<th scope="row" class="row-header">Description</th>
<td class="content-container"><div><p>25°C/60% RH</p>
</div></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Long-Term)</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Initial</td>
</tr>
<tr>
<th scope="row" class="row-header">Timing</th>
<td class="content-container">Once</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">PlanDefinition Sub-Action (Parent Action Title: Initial)</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">XYZ</td>
</tr>
<tr>
<th scope="row" class="row-header">Definition</th>
<td class="content-container"><code>http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90</code></td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">Generated using version 0.5.4 of the sample-content-ig Liquid templates</th>
</tr>
</tbody>
</table>
</div>
</text>
<url
value="http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol"/>
<title value="Stability Monitoring Program"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type"/>
<code value="1244588"/>
<display value="Stability Study Protocol"/>
</coding>
</type>
<status value="active"/>
<subjectReference>🔗
<reference
value="MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"/>
</subjectReference>
<description value="Narrative description of Stability Study"/>
<action>
<title
value="Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg"/>
<action>
<title value="Long-Term"/>
<description value="25°C/60% RH"/>
<action>
<title value="Initial"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="0"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="0"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="XYZ"/>
<definitionCanonical
value="http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"/>
</action>
</action>
</action>
</action>
</PlanDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.com/ActivityDefinition/activitydefinition-test-drug-pq-ex1"/>
<resource>
<ActivityDefinition>
<id value="activitydefinition-test-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ActivityDefinition_activitydefinition-test-drug-pq-ex1"> </a>
<table class="narrative-table">
<tbody>
<tr>
<th colspan="2" scope="row" class="row-header">Metadata</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ.</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">Generated using version 0.5.4 of the sample-content-ig Liquid templates</th>
</tr>
</tbody>
</table>
</div>
</text>
<url
value="http://example-server.com/fhir/ActivityDefinition/activitydefinition-test-drug-pq-ex1"/>
<title
value="Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ."/>
<status value="active"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.com/ObservationDefinition/accelerated40X"/>
<resource>
<ObservationDefinition>
<id value="accelerated40X"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_accelerated40X"> </a><p class="res-header-id"><b>Generated Narrative: ObservationDefinition accelerated40X</b></p><a name="accelerated40X"> </a><a name="hcaccelerated40X"> </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-ObservationDefinition-test-method-drug-pq.html">ObservationDefinition - Test Method PQ</a></p></div><p><b>status</b>: Active</p><p><b>code</b>: <span title="Codes:">Battery of tests 'X' at 40°C/75% RH</span></p></div>
</text>
<status value="active"/>
<code>
<text value="Battery of tests 'X' at 40°C/75% RH"/>
</code>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.com/DiagnosticReport/diagnosticreport-analysis-drug-pq-stability-prod"/>
<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="http://example.com/Observation/observation-test-result-longterm25c-initial-1"/>
<resource>
<Observation>
<id value="observation-test-result-longterm25c-initial-1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Observation_observation-test-result-longterm25c-initial-1"> </a><p class="res-header-id"><b>Generated Narrative: Observation observation-test-result-longterm25c-initial-1</b></p><a name="observation-test-result-longterm25c-initial-1"> </a><a name="hcobservation-test-result-longterm25c-initial-1"> </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>Triggered by</b>: <a href="ActivityDefinition-activitydefinition-test-drug-pq-ex1.html">Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ.</a></p><p><b>status</b>: Final</p><p><b>code</b>: <span title="Codes:">Test Components - Long-term 25C etc - Initial (XYZ)</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>specimen</b>: <a href="Specimen-specimen-drug-pq-ex1.html">Specimen</a></p><p><b>hasMember</b>: </p><ul><li><a href="Observation-observation-test-result-lt25c-i1-description.html">Observation Description</a></li><li><a href="Observation-observation-test-result-lt25c-i1-degradation-imp1.html">Observation Degradation Products</a></li><li><a href="Observation-observation-test-result-lt25c-i1-degradation-imp2.html">Observation Degradation Products</a></li><li><a href="Observation-observation-test-result-lt25c-i1-degradation-imp3.html">Observation Degradation Products</a></li><li><a href="Observation-observation-test-result-lt25c-i1-degradation-imp-unspecified.html">Observation Degradation Products</a></li><li><a href="Observation-observation-test-result-lt25c-i1-degradation-imp-total.html">Observation Degradation Products</a></li><li><a href="Observation-observation-test-result-lt25c-i1-water.html">Observation Water Content</a></li><li><a href="Observation-observation-test-result-lt25c-i1-microbiological.html">Observation Microbiological Quality</a></li><li><a href="Observation-observation-test-result-lt25c-i1-uniformity.html">Observation Uniformity of dosage units (by weight)</a></li></ul></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>🔗
<reference
value="ActivityDefinition/activitydefinition-test-drug-pq-ex1"/>
</valueReference>
</extension>
<status value="final"/>
<code>
<text value="Test Components - Long-term 25C etc - Initial (XYZ)"/>
</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>
<specimen>🔗
<reference value="Specimen/specimen-drug-pq-ex1"/>
</specimen>
<hasMember>🔗
<reference
value="Observation/observation-test-result-lt25c-i1-description"/>
</hasMember>
<hasMember>🔗
<reference
value="Observation/observation-test-result-lt25c-i1-degradation-imp1"/>
</hasMember>
<hasMember>🔗
<reference
value="Observation/observation-test-result-lt25c-i1-degradation-imp2"/>
</hasMember>
<hasMember>🔗
<reference
value="Observation/observation-test-result-lt25c-i1-degradation-imp3"/>
</hasMember>
<hasMember>🔗
<reference
value="Observation/observation-test-result-lt25c-i1-degradation-imp-unspecified"/>
</hasMember>
<hasMember>🔗
<reference
value="Observation/observation-test-result-lt25c-i1-degradation-imp-total"/>
</hasMember>
<hasMember>🔗
<reference
value="Observation/observation-test-result-lt25c-i1-water"/>
</hasMember>
<hasMember>🔗
<reference
value="Observation/observation-test-result-lt25c-i1-microbiological"/>
</hasMember>
<hasMember>🔗
<reference
value="Observation/observation-test-result-lt25c-i1-uniformity"/>
</hasMember>
</Observation>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.com/Organization/organization-drug-pq-ex1"/>
<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>
<entry>
<fullUrl
value="http://example.com/Organization/organization-drug-pq-ex1"/>
<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><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>
<entry>
<fullUrl
value="http://example.com/Organization/organization-drug-pq-ex1"/>
<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><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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