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
<!-- Product Stability Study -->
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundle-drug-stability-pq-ex1-prod"/>
<!-- <id value="product-stability-study"/> -->
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-stability-pq"/>
</meta>
<type value="collection"/>
<!-- Section 11 - Stability Study - Results -->
<entry>
<fullUrl value="urn:uuid:6f4a3311-92c5-2b4a-533e-76341e414c63"/>
<resource>
<DiagnosticReport>
<!-- <id value="studyResultsReport"/> -->
<id value="diagnosticreport-analysis-drug-pq-stability-prod"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: DiagnosticReport</b><a name="diagnosticreport-analysis-drug-pq-stability-prod"> </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 DiagnosticReport "diagnosticreport-analysis-drug-pq-stability-prod" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-DiagnosticReport-analysis-drug-pq.html">DiagnosticReport - Analysis Drug PQ</a></p></div><p><b>Triggered by</b>: <a href="#PlanDefinition_c96cb248-1408-79fc-1f47-b17a6b2e4b54">See above (PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54)</a></p><p><b>Extension - Statistical Model PQ</b>: information about statistical model utilized to interpret stability study results <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>Extension - Container Orientation PQ</b>: Horizontal <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-containerOrientation-local-pq.html">CodeSystem - Container Orientation</a>#horizontal "horizontal")</span></p><p><b>identifier</b>: id: ABC1234</p><p><b>status</b>: final</p><p><b>code</b>: Stability Study Report - 18 months <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-reportType-local-pq.html">CodeSystem - Report Type</a>#Stability Study Report - 18 months)</span></p><p><b>effective</b>: 2020-12</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>result</b>: </p><ul><li><a href="#Observation_6fabbf78-9678-8030-485f-b149956308d5">See above (Observation/6fabbf78-9678-8030-485f-b149956308d5)</a></li><li><a href="#Observation_74535cc6-5232-5ab5-81cf-167a480795e5">See above (Observation/74535cc6-5232-5ab5-81cf-167a480795e5)</a></li><li><a href="#Observation_8bf75da1-9221-66fe-6725-c64cb45a57e6">See above (Observation/8bf75da1-9221-66fe-6725-c64cb45a57e6)</a></li><li><a href="#Observation_e803ad6d-0cb3-87dd-6af1-4b88c654a47c">See above (Observation/e803ad6d-0cb3-87dd-6af1-4b88c654a47c)</a></li><li><a href="#Observation_3519f84a-2889-90a0-a6b7-ff2f1be66a73">See above (Observation/3519f84a-2889-90a0-a6b7-ff2f1be66a73)</a></li><li><a href="#Observation_2ef362f1-0b65-3578-7f06-fbd74a24694a">See above (Observation/2ef362f1-0b65-3578-7f06-fbd74a24694a)</a></li><li><a href="#Observation_72e0640b-094b-909e-5268-3dee92af4bbd">See above (Observation/72e0640b-094b-909e-5268-3dee92af4bbd)</a></li></ul><p><b>conclusion</b>: The samples have been assessed and the conclusion is that the shelf life can be 18 months.</p></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>
<!-- PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol -->
<reference
value="PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54"/>
</valueReference>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq">
<valueCodeableConcept>
<!-- Want to use studyDesign, but problem is that this is CodeableConcept, which allows text. However when you use text, you then
have no place to put a context. Ideally this would be a code/code pair.
Code says "statistical model", code (or text) then says what it is -->
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-containerOrientation-local-pq"/>
<code value="horizontal"/>
<display value="horizontal"/>
</coding>
<!-- Considered ObservatioDefinition.usageContext -->
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-reportType-local-pq"/>
<code value="Stability Study Report - 18 months"/>
<display value="Stability Study Report - 18 months"/>
</coding>
</code>
<effectiveDateTime value="2020-12">
<!-- start of stability test -->
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-timePointDescription-local-pq"/>
<code value="Delayed Start Code"/>
<display value="Delayed Start Code"/>
</coding>
<text value="Refrigerated delayed testing"/>
</valueCodeableConcept>
</extension>
</effectiveDateTime>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<result>
<!-- Observation/observation-test-result-longterm25c-initial-1 -->
<reference
value="Observation/6fabbf78-9678-8030-485f-b149956308d5"/>
</result>
<result>
<!-- Observation/LongTerm25C-initial-2 -->
<reference
value="Observation/74535cc6-5232-5ab5-81cf-167a480795e5"/>
</result>
<result>
<!-- Observation/LongTerm25C-initial-3 -->
<reference
value="Observation/8bf75da1-9221-66fe-6725-c64cb45a57e6"/>
</result>
<!-- skipping middle months -->
<result>
<!-- Observation/LongTerm25C-18m-1 -->
<reference
value="Observation/e803ad6d-0cb3-87dd-6af1-4b88c654a47c"/>
</result>
<result>
<!-- Observation/LongTerm25C-18m-2 -->
<reference
value="Observation/3519f84a-2889-90a0-a6b7-ff2f1be66a73"/>
</result>
<result>
<!-- Observation/LongTerm25C-18m-3 -->
<reference
value="Observation/2ef362f1-0b65-3578-7f06-fbd74a24694a"/>
</result>
<!-- Accelerated -->
<result>
<!-- Observation/Accelerated40C-3-1 -->
<reference
value="Observation/72e0640b-094b-909e-5268-3dee92af4bbd"/>
</result>
<!-- skipping rest of Accelerated -->
<conclusion
value="The samples have been assessed and the conclusion is that the shelf life can be 18 months."/>
</DiagnosticReport>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:c96cb248-1408-79fc-1f47-b17a6b2e4b54"/>
<!-- Section 11 - Stability Study - Protocol -->
<!-- end of accelerated -->
<resource>
<PlanDefinition>
<!-- <id value="stabilityStudyProtocol"/> -->
<!-- id value="plandefinition-stability-study-protocol-dxpq-ex1"/ -->
<!-- plandefinition-drug-pq-ex5-stability-study-protocol -->
<id value="c96cb248-1408-79fc-1f47-b17a6b2e4b54"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PlanDefinition</b><a name="c96cb248-1408-79fc-1f47-b17a6b2e4b54"> </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 PlanDefinition "c96cb248-1408-79fc-1f47-b17a6b2e4b54" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PlanDefinition-drug-pq.html">PlanDefinition - Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54</code></p><p><b>title</b>: Stability Monitoring Program</p><p><b>type</b>: Stability Study Protocol <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (planType#1244588)</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href="#MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5">See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)</a></p><p><b>description</b>: Narrative description of Stability Study</p><blockquote><p><b>action</b></p><p><b>title</b>: Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg</p><blockquote><p><b>action</b></p><p><b>title</b>: Long-Term</p><p><b>description</b>: 25°C/60% RH</p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Accelerated</p><p><b>description</b>: 40°C/75% RH</p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote></div>
</text>
<!-- http://example-server.com/fhir/PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54 -->
<url
value="http://example-server.com/fhir/PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54"/>
<title value="Stability Monitoring Program"/>
<!-- Added type (8/22/2023) -->
<type>
<coding>
<system value="http://example.org/fhir/code/planType"/>
<code value="1244588"/>
<display value="Stability Study Protocol"/>
</coding>
</type>
<status value="active"/>
<subjectReference>
<!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1 -->
<reference
value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
</subjectReference>
<description value="Narrative description of Stability Study"/>
<action>
<!-- this is then entire thing -->
<title
value="Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg"/>
<action>
<!-- TODO add codes here for the different levels? -->
<title value="Long-Term"/>
<description value="25°C/60% RH"/>
<action>
<!-- 0 months -->
<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>
<!-- the categories to do at this step -->
<title value="XYZ"/>
<!-- Long term -->
<!-- ActivityDefinition/activitydefinition-test-drug-pq-ex1 -->
<definitionCanonical
value="ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"/>
</action>
</action>
<!-- 3 months -->
<!-- todo put comments back in? -->
<action>
<title value="3"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="3"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="3"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="X"/>
<!-- ActivityDefinition/activitydefinition-stability-test-dxpq-ex1 -->
<definitionCanonical
value="ActivityDefinition/610ca25c-6126-6117-8d4d-9458ccc33ce2"/>
</action>
</action>
<!-- 6 months -->
<action>
<title value="6"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="6"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="6"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="X"/>
<!-- ActivityDefinition/activityLongTerm25X-6 -->
<definitionCanonical
value="ActivityDefinition/d99c1b63-2d32-4887-8157-525cc8ae4732"/>
</action>
</action>
<!-- 9 months -->
<action>
<title value="9"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="9"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="9"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="X"/>
<!-- ActivityDefinition/activityLongTerm25X-9 -->
<definitionCanonical
value="ActivityDefinition/38704856-0acf-95f0-000f-a933b6862fa0"/>
</action>
</action>
<!-- 12 months -->
<action>
<title value="12"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="12"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="12"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="XY"/>
<!-- ActivityDefinition/activityLongTerm25XY-12 -->
<definitionCanonical
value="ActivityDefinition/f19a68b0-4ba1-7288-635e-12783035935b"/>
</action>
</action>
<!-- 18 months -->
<action>
<title value="18"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="18"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="18"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="XY"/>
<!-- ActivityDefinition/activityLongTerm25XY-18 -->
<definitionCanonical
value="ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2"/>
</action>
</action>
<!-- 24 months -->
<action>
<title value="24"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="24"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="24"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="XY"/>
<!-- ActivityDefinition/activityLongTerm25XY-24 -->
<definitionCanonical
value="ActivityDefinition/cf2df6ab-5087-435c-35cb-a84572e756a2"/>
</action>
</action>
</action>
<!-- end of long term -->
<!-- 0 months is first one - but results for this are not needed, because and zero months is the same for both long term and accelerated -->
<action>
<title value="Accelerated"/>
<description value="40°C/75% 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"/>
<!-- ActivityDefinition/activityAccelerated40XYZ-Initial -->
<definitionCanonical
value="ActivityDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"/>
</action>
</action>
<action>
<title value="3"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="3"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="3"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="X"/>
<!-- ActivityDefinition/activityAccelerated40X-3 -->
<definitionCanonical
value="ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50"/>
</action>
</action>
<action>
<title value="6"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="6"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="6"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="X"/>
<!-- ActivityDefinition/activityAccelerated40X-6 -->
<definitionCanonical
value="ActivityDefinition/77f86b13-8193-3df7-8362-ab5e79ba541d"/>
</action>
</action>
<action>
<title value="9"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="9"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="9"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="-"/>
</action>
</action>
<action>
<title value="12"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="12"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="12"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="-"/>
</action>
</action>
<action>
<title value="18"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="18"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="18"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="-"/>
</action>
</action>
<action>
<title value="24"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="24"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="24"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="-"/>
</action>
</action>
</action>
</action>
</PlanDefinition>
</resource>
</entry>
<!-- Long term tests -->
<entry>
<fullUrl value="urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
<resource>
<SpecimenDefinition>
<!-- <id value="specimenDefStoredAt25"/> -->
<!-- specimendefinition-drug-pq-ex1 -->
<id value="3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SpecimenDefinition</b><a name="3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"> </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 SpecimenDefinition "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SpecimenDefinition-drug-pq.html">SpecimenDefinition - Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2</code></p><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>25°C/60% RH</td></tr></table></blockquote></div>
</text>
<!-- http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2 -->
<url
value="http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
<status value="active"/>
<typeTested>
<preference value="preferred"/>
<handling>
<instruction value="25°C/60% RH"/>
</handling>
</typeTested>
</SpecimenDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:610ca25c-6126-6117-8d4d-9458ccc33ce2"/>
<resource>
<ActivityDefinition>
<!-- <id value="activityLongTerm25X-3"/> -->
<!-- activitydefinition-stability-test-dxpq-ex1 -->
<id value="610ca25c-6126-6117-8d4d-9458ccc33ce2"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="610ca25c-6126-6117-8d4d-9458ccc33ce2"> </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 ActivityDefinition "610ca25c-6126-6117-8d4d-9458ccc33ce2" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ActivityDefinition-test-drug-pq.html">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/610ca25c-6126-6117-8d4d-9458ccc33ce2</code></p><p><b>title</b>: Long-term - 25°C/60% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774">http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/610ca25c-6126-6117-8d4d-9458ccc33ce2 -->
<url
value="http://example-server.com/fhir/ActivityDefinition/610ca25c-6126-6117-8d4d-9458ccc33ce2"/>
<title value="Long-term - 25°C/60% RH - X"/>
<status value="active"/>
<!-- changed here to not have url in front -->
<!-- ObservationDefinition/longTerm25X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:d99c1b63-2d32-4887-8157-525cc8ae4732"/>
<resource>
<ActivityDefinition>
<!-- activityLongTerm25X-6 -->
<id value="d99c1b63-2d32-4887-8157-525cc8ae4732"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="d99c1b63-2d32-4887-8157-525cc8ae4732"> </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 ActivityDefinition "d99c1b63-2d32-4887-8157-525cc8ae4732" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ActivityDefinition-test-drug-pq.html">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/d99c1b63-2d32-4887-8157-525cc8ae4732</code></p><p><b>title</b>: Long-term - 25°C/60% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774">http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/d99c1b63-2d32-4887-8157-525cc8ae4732 -->
<url
value="http://example-server.com/fhir/ActivityDefinition/d99c1b63-2d32-4887-8157-525cc8ae4732"/>
<title value="Long-term - 25°C/60% RH - X"/>
<status value="active"/>
<!-- ObservationDefinition/longTerm25X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:38704856-0acf-95f0-000f-a933b6862fa0"/>
<resource>
<ActivityDefinition>
<!-- activityLongTerm25X-9 -->
<id value="38704856-0acf-95f0-000f-a933b6862fa0"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="38704856-0acf-95f0-000f-a933b6862fa0"> </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 ActivityDefinition "38704856-0acf-95f0-000f-a933b6862fa0" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ActivityDefinition-test-drug-pq.html">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/38704856-0acf-95f0-000f-a933b6862fa0</code></p><p><b>title</b>: Long-term - 25°C/60% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774">http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/38704856-0acf-95f0-000f-a933b6862fa0 -->
<url
value="http://example-server.com/fhir/ActivityDefinition/38704856-0acf-95f0-000f-a933b6862fa0"/>
<title value="Long-term - 25°C/60% RH - X"/>
<status value="active"/>
<!-- ObservationDefinition/longTerm25X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"/>
<resource>
<ActivityDefinition>
<!-- id value="activityLongTerm25XYZ-Initial"/ -->
<!-- activitydefinition-test-drug-pq-ex1 -->
<id value="4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"> </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 ActivityDefinition "4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ActivityDefinition-test-drug-pq.html">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90</code></p><p><b>title</b>: Long-term - 25°C/60% RH - XYZ</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774">http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774</a>, <a href="http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851">http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851</a>, <a href="http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409">http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90 -->
<url
value="http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"/>
<title value="Long-term - 25°C/60% RH - XYZ"/>
<status value="active"/>
<!-- ObservationDefinition/longTerm25X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774"/>
<!-- ObservationDefinition/longTerm25Y -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851"/>
<!-- ObservationDefinition/longTerm25Z -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:f19a68b0-4ba1-7288-635e-12783035935b"/>
<resource>
<ActivityDefinition>
<!-- activityLongTerm25XY-12 -->
<id value="f19a68b0-4ba1-7288-635e-12783035935b"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="f19a68b0-4ba1-7288-635e-12783035935b"> </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 ActivityDefinition "f19a68b0-4ba1-7288-635e-12783035935b" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ActivityDefinition-test-drug-pq.html">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/f19a68b0-4ba1-7288-635e-12783035935b</code></p><p><b>title</b>: Long-term - 25°C/60% RH - XY</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774">http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774</a>, <a href="http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851">http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/f19a68b0-4ba1-7288-635e-12783035935b -->
<url
value="http://example-server.com/fhir/ActivityDefinition/f19a68b0-4ba1-7288-635e-12783035935b"/>
<title value="Long-term - 25°C/60% RH - XY"/>
<status value="active"/>
<!-- ObservationDefinition/longTerm25X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774"/>
<!-- ObservationDefinition/longTerm25Y -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:ce2df6ab-5087-435c-35cb-a84572e756a2"/>
<resource>
<ActivityDefinition>
<!-- activityLongTerm25XY-18 -->
<id value="ce2df6ab-5087-435c-35cb-a84572e756a2"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="ce2df6ab-5087-435c-35cb-a84572e756a2"> </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 ActivityDefinition "ce2df6ab-5087-435c-35cb-a84572e756a2" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ActivityDefinition-test-drug-pq.html">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2</code></p><p><b>title</b>: Long-term - 25°C/60% RH - XY</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774">http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774</a>, <a href="http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851">http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2 -->
<url
value="http://example-server.com/fhir/ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2"/>
<title value="Long-term - 25°C/60% RH - XY"/>
<status value="active"/>
<!-- ObservationDefinition/longTerm25X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774"/>
<!-- ObservationDefinition/longTerm25Y -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:cf2df6ab-5087-435c-35cb-a84572e756a2"/>
<resource>
<ActivityDefinition>
<!-- activityLongTerm25XY-24 -->
<id value="cf2df6ab-5087-435c-35cb-a84572e756a2"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="cf2df6ab-5087-435c-35cb-a84572e756a2"> </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 ActivityDefinition "cf2df6ab-5087-435c-35cb-a84572e756a2" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ActivityDefinition-test-drug-pq.html">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/cf2df6ab-5087-435c-35cb-a84572e756a2</code></p><p><b>title</b>: Long-term - 25°C/60% RH - XY</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774">http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774</a>, <a href="http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851">http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/cf2df6ab-5087-435c-35cb-a84572e756a2 -->
<url
value="http://example-server.com/fhir/ActivityDefinition/cf2df6ab-5087-435c-35cb-a84572e756a2"/>
<title value="Long-term - 25°C/60% RH - XY"/>
<status value="active"/>
<!-- ObservationDefinition/longTerm25X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774"/>
<!-- ObservationDefinition/longTerm25Y -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:d1d252cf-9d58-43a0-85f6-56a7f7f92774"/>
<!-- can have others -->
<resource>
<ObservationDefinition>
<!-- longTerm25X -->
<id value="d1d252cf-9d58-43a0-85f6-56a7f7f92774"/>
<!-- id value="observationdefinition-test-method-drug-pq-ex1"/ -->
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="d1d252cf-9d58-43a0-85f6-56a7f7f92774"> </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 ObservationDefinition "d1d252cf-9d58-43a0-85f6-56a7f7f92774" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ObservationDefinition-test-method-drug-pq.html">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774</code></p><p><b>title</b>: X</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'X' at 25°C/60% RH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>specimen</b>: <a href="#SpecimenDefinition_3a0cde98-4a73-6d67-1dfc-08e3fc9646a2">See above (SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2)</a></p><p><b>hasMember</b>: </p><ul><li><a href="#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></li><li><a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></li><li><a href="#ObservationDefinition_186eb33e-a01d-4252-166c-b5ba5e8a697c">See above (ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c)</a></li></ul></div>
</text>
<!-- http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/observationdefinition-test-method-drug-pq-ex1 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774"/>
<title value="X"/>
<status value="active"/>
<code>
<text value="Battery of tests 'X' at 25°C/60% RH"/>
</code>
<specimen>
<!-- SpecimenDefinition/specimendefinition-drug-pq-ex1 -->
<reference
value="SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
</specimen>
<hasMember>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"/>
</hasMember>
<hasMember>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</hasMember>
<hasMember>
<!-- ObservationDefinition/Water -->
<reference
value="ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c"/>
</hasMember>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:1178fc31-0cfd-8c60-0b5b-9ae2850c6774"/>
<resource>
<ObservationDefinition>
<!-- Description -->
<id value="1178fc31-0cfd-8c60-0b5b-9ae2850c6774"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="1178fc31-0cfd-8c60-0b5b-9ae2850c6774"> </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 ObservationDefinition "1178fc31-0cfd-8c60-0b5b-9ae2850c6774" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ObservationDefinition-test-method-drug-pq.html">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774</code></p><p><b>title</b>: Description</p><p><b>status</b>: active</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"/>
<title value="Description"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString
value="An orange film-coated tablet, debossed with 175 on one side"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:2c5683d6-6e94-825b-056a-129a04c95e2f"/>
<resource>
<ObservationDefinition>
<!-- Degradation -->
<id value="2c5683d6-6e94-825b-056a-129a04c95e2f"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="2c5683d6-6e94-825b-056a-129a04c95e2f"> </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 ObservationDefinition "2c5683d6-6e94-825b-056a-129a04c95e2f" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ObservationDefinition-test-method-drug-pq.html">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</code></p><p><b>title</b>: Degradation Products by HPLC (% w/w)</p><p><b>status</b>: active</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 1 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.8</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.4</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 3 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.4</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Any Unspecified Degradation Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.2</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total Degradation Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-2.3</p></blockquote><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f -->
<url
value="http://example-server.com/fhir/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
<title value="Degradation Products by HPLC (% w/w)"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
</code>
<qualifiedValue>
<appliesTo>
<!-- could be a code -->
<text value="Impurity 1"/>
</appliesTo>
<range>
<high>
<value value="0.8"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Impurity 2"/>
</appliesTo>
<range>
<high>
<value value="0.4"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Impurity 3"/>
</appliesTo>
<range>
<high>
<value value="0.4"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Any Unspecified Degradation Impurity"/>
</appliesTo>
<range>
<high>
<value value="0.2"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Total Degradation Impurities"/>
</appliesTo>
<range>
<high>
<value value="2.3"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
<component>
<!-- are expected to have a component that says what impurity this one is -->
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
</component>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:186eb33e-a01d-4252-166c-b5ba5e8a697c"/>
<resource>
<ObservationDefinition>
<!-- Water -->
<id value="186eb33e-a01d-4252-166c-b5ba5e8a697c"/>
<!-- id value="observationdefinition-test-method-drug-pq-ex2"/ -->
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="186eb33e-a01d-4252-166c-b5ba5e8a697c"> </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 ObservationDefinition "186eb33e-a01d-4252-166c-b5ba5e8a697c" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ObservationDefinition-test-method-drug-pq.html">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c</code></p><p><b>title</b>: Water Content (% w/w) (Mean)</p><p><b>status</b>: active</p><p><b>code</b>: Water Content <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td>?-0.2</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c -->
<url
value="http://example-server.com/fhir/ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c"/>
<title value="Water Content (% w/w) (Mean)"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="WaterContent"/>
<display value="Water Content"/>
</coding>
<text value="Water Content"/>
</code>
<qualifiedValue>
<range>
<high>
<value value="0.2"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:b62b9524-53af-84ae-1071-2867a2169851"/>
<!-- can have others -->
<resource>
<ObservationDefinition>
<!-- longTerm25Y -->
<id value="b62b9524-53af-84ae-1071-2867a2169851"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="b62b9524-53af-84ae-1071-2867a2169851"> </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 ObservationDefinition "b62b9524-53af-84ae-1071-2867a2169851" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ObservationDefinition-test-method-drug-pq.html">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851</code></p><p><b>title</b>: Y</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'Y' at 25°C/60% RH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>specimen</b>: <a href="#SpecimenDefinition_3a0cde98-4a73-6d67-1dfc-08e3fc9646a2">See above (SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2)</a></p><p><b>hasMember</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851"/>
<title value="Y"/>
<status value="active"/>
<code>
<text value="Battery of tests 'Y' at 25°C/60% RH"/>
</code>
<specimen>
<!-- SpecimenDefinition/specimendefinition-drug-pq-ex1 -->
<reference
value="SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
</specimen>
<hasMember>
<!-- ObservationDefinition/Microbiological -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</hasMember>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:73d9d304-a0b8-31b6-1165-346563b9305e"/>
<resource>
<ObservationDefinition>
<!-- Microbiological -->
<id value="73d9d304-a0b8-31b6-1165-346563b9305e"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="73d9d304-a0b8-31b6-1165-346563b9305e"> </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 ObservationDefinition "73d9d304-a0b8-31b6-1165-346563b9305e" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ObservationDefinition-test-method-drug-pq.html">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</code></p><p><b>title</b>: Microbiological</p><p><b>status</b>: active</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e -->
<url
value="http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
<title value="Microbiological"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Microbiological Quality"/>
<display value="Microbiological Quality"/>
</coding>
<text value="Microbiological Quality"/>
</code>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString value="Complies with PhEur"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:363384c8-0d79-5ff0-5538-4933f99d6409"/>
<!-- can have others -->
<resource>
<ObservationDefinition>
<!-- longTerm25Z -->
<id value="363384c8-0d79-5ff0-5538-4933f99d6409"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="363384c8-0d79-5ff0-5538-4933f99d6409"> </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 ObservationDefinition "363384c8-0d79-5ff0-5538-4933f99d6409" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ObservationDefinition-test-method-drug-pq.html">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409</code></p><p><b>title</b>: Z</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'Z' at 25°C/60% RH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>specimen</b>: <a href="#SpecimenDefinition_3a0cde98-4a73-6d67-1dfc-08e3fc9646a2">See above (SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2)</a></p><p><b>hasMember</b>: <a href="#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8">See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)</a></p></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409"/>
<title value="Z"/>
<status value="active"/>
<code>
<text value="Battery of tests 'Z' at 25°C/60% RH"/>
</code>
<specimen>
<!-- SpecimenDefinition/specimendefinition-drug-pq-ex1 -->
<reference
value="SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
</specimen>
<hasMember>
<!-- ObservationDefinition/Uniformity -->
<reference
value="ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8"/>
</hasMember>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:ef781c18-8e86-7859-209b-469ee9ad42d8"/>
<resource>
<ObservationDefinition>
<!-- Uniformity -->
<id value="ef781c18-8e86-7859-209b-469ee9ad42d8"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="ef781c18-8e86-7859-209b-469ee9ad42d8"> </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 ObservationDefinition "ef781c18-8e86-7859-209b-469ee9ad42d8" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ObservationDefinition-test-method-drug-pq.html">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8</code></p><p><b>title</b>: Uniformity of dosage</p><p><b>status</b>: active</p><p><b>code</b>: uniformity of dosage units (by weight) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8"/>
<title value="Uniformity of dosage"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="uniformity-dosage"/>
<display value="uniformity of dosage units (by weight)"/>
</coding>
<text value="uniformity of dosage units (by weight)"/>
</code>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString value="Complies"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<!-- Accelerated tests -->
<entry>
<fullUrl value="urn:uuid:e95109ac-5ef9-1723-3506-2ef2f2e33d87"/>
<resource>
<SpecimenDefinition>
<!-- specimenDefStoredAt40 -->
<id value="e95109ac-5ef9-1723-3506-2ef2f2e33d87"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SpecimenDefinition</b><a name="e95109ac-5ef9-1723-3506-2ef2f2e33d87"> </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 SpecimenDefinition "e95109ac-5ef9-1723-3506-2ef2f2e33d87" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87</code></p><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>40°C/75% RH</td></tr></table></blockquote></div>
</text>
<!-- http://example-server.com/fhir/SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87 -->
<url
value="http://example-server.com/fhir/SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87"/>
<status value="active"/>
<typeTested>
<preference value="preferred"/>
<handling>
<instruction value="40°C/75% RH"/>
</handling>
</typeTested>
</SpecimenDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:096e3f32-798e-6792-76ad-4ea783521c50"/>
<resource>
<ActivityDefinition>
<!-- activityAccelerated40X-3 -->
<id value="096e3f32-798e-6792-76ad-4ea783521c50"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="096e3f32-798e-6792-76ad-4ea783521c50"> </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 ActivityDefinition "096e3f32-798e-6792-76ad-4ea783521c50" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ActivityDefinition-test-drug-pq.html">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50</code></p><p><b>title</b>: Accelerated - 40°C/70% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b">http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50 -->
<url
value="http://example-server.com/fhir/ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50"/>
<title value="Accelerated - 40°C/70% RH - X"/>
<status value="active"/>
<!-- ObservationDefinition/accelerated40X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:77f86b13-8193-3df7-8362-ab5e79ba541d"/>
<resource>
<ActivityDefinition>
<!-- activityAccelerated40X-6 -->
<id value="77f86b13-8193-3df7-8362-ab5e79ba541d"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="77f86b13-8193-3df7-8362-ab5e79ba541d"> </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 ActivityDefinition "77f86b13-8193-3df7-8362-ab5e79ba541d" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ActivityDefinition-test-drug-pq.html">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/77f86b13-8193-3df7-8362-ab5e79ba541d</code></p><p><b>title</b>: Accelerated - 40°C/70% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b">http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/77f86b13-8193-3df7-8362-ab5e79ba541d -->
<url
value="http://example-server.com/fhir/ActivityDefinition/77f86b13-8193-3df7-8362-ab5e79ba541d"/>
<title value="Accelerated - 40°C/70% RH - X"/>
<status value="active"/>
<!-- ObservationDefinition/accelerated40X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:6b96124b-1a44-0b6b-6783-d6c49360230b"/>
<resource>
<ActivityDefinition>
<!-- activityAccelerated40XYZ-Initial -->
<id value="6b96124b-1a44-0b6b-6783-d6c49360230b"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ActivityDefinition</b><a name="6b96124b-1a44-0b6b-6783-d6c49360230b"> </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 ActivityDefinition "6b96124b-1a44-0b6b-6783-d6c49360230b" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ActivityDefinition-test-drug-pq.html">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</code></p><p><b>title</b>: Accelerated - 40°C/70% RH - XYZ</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href="http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b">http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b</a>, <a href="http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2">http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2</a>, <a href="http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0">http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0</a></p></div>
</text>
<!-- http://example-server.com/fhir/ActivityDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b -->
<url
value="http://example-server.com/fhir/ActivityDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"/>
<title value="Accelerated - 40°C/70% RH - XYZ"/>
<status value="active"/>
<!-- ObservationDefinition/accelerated40X -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b"/>
<!-- ObservationDefinition/accelerated40Y -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2"/>
<!-- ObservationDefinition/accelerated40Z -->
<observationRequirement
value="http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0"/>
</ActivityDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b"/>
<!-- can have others -->
<resource>
<ObservationDefinition>
<!-- accelerated40X -->
<id value="792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b"> </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 ObservationDefinition "792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ObservationDefinition-test-method-drug-pq.html">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b</code></p><p><b>title</b>: X</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'X' at 40°C/75% RH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>specimen</b>: <a href="#SpecimenDefinition_e95109ac-5ef9-1723-3506-2ef2f2e33d87">See above (SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87)</a></p><p><b>hasMember</b>: </p><ul><li><a href="#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></li><li><a href="#ObservationDefinition_186eb33e-a01d-4252-166c-b5ba5e8a697c">See above (ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c)</a></li></ul></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b -->
<url
value="http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b"/>
<title value="X"/>
<status value="active"/>
<code>
<text value="Battery of tests 'X' at 40°C/75% RH"/>
</code>
<specimen>
<!-- SpecimenDefinition/specimenDefStoredAt40 -->
<reference
value="SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87"/>
</specimen>
<hasMember>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"/>
</hasMember>
<hasMember>
<!-- ObservationDefinition/Water -->
<reference
value="ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c"/>
</hasMember>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:58cb0710-0ee6-1b7a-2a64-61a01df95ac2"/>
<!-- can have others -->
<resource>
<ObservationDefinition>
<!-- accelerated40Y -->
<id value="58cb0710-0ee6-1b7a-2a64-61a01df95ac2"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="58cb0710-0ee6-1b7a-2a64-61a01df95ac2"> </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 ObservationDefinition "58cb0710-0ee6-1b7a-2a64-61a01df95ac2" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ObservationDefinition-test-method-drug-pq.html">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2</code></p><p><b>title</b>: Y</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'Y' at 40°C/75% RH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>specimen</b>: <a href="#SpecimenDefinition_e95109ac-5ef9-1723-3506-2ef2f2e33d87">See above (SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87)</a></p><p><b>hasMember</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2"/>
<title value="Y"/>
<status value="active"/>
<code>
<text value="Battery of tests 'Y' at 40°C/75% RH"/>
</code>
<specimen>
<!-- SpecimenDefinition/specimenDefStoredAt40 -->
<reference
value="SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87"/>
</specimen>
<hasMember>
<!-- ObservationDefinition/Microbiological -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</hasMember>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9bc183ee-6017-789b-8a6f-6a5c339f9ae0"/>
<!-- can have others -->
<resource>
<ObservationDefinition>
<!-- accelerated40Z -->
<id value="9bc183ee-6017-789b-8a6f-6a5c339f9ae0"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="9bc183ee-6017-789b-8a6f-6a5c339f9ae0"> </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 ObservationDefinition "9bc183ee-6017-789b-8a6f-6a5c339f9ae0" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ObservationDefinition-test-method-drug-pq.html">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0</code></p><p><b>title</b>: Z</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'Z' at 25°C/60% RH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>specimen</b>: <a href="#SpecimenDefinition_e95109ac-5ef9-1723-3506-2ef2f2e33d87">See above (SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87)</a></p><p><b>hasMember</b>: <a href="#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8">See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)</a></p></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0"/>
<title value="Z"/>
<status value="active"/>
<code>
<text value="Battery of tests 'Z' at 25°C/60% RH"/>
</code>
<specimen>
<!-- SpecimenDefinition/specimenDefStoredAt40 -->
<reference
value="SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87"/>
</specimen>
<hasMember>
<!-- ObservationDefinition/Uniformity -->
<reference
value="ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8"/>
</hasMember>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd"/>
<resource>
<Specimen>
<!-- id value="stabilityInitial-1"/ -->
<!-- specimen-drug-pq-ex1 -->
<id value="b664977d-799d-a1ce-928a-5def2a9955bd"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Specimen</b><a name="b664977d-799d-a1ce-928a-5def2a9955bd"> </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 Specimen "b664977d-799d-a1ce-928a-5def2a9955bd" </p><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>
<!-- when sample first taken, before the timed periods start -->
<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="urn:uuid:b664977d-799d-a1ce-928a-5def2a9955be"/>
<resource>
<Specimen>
<!-- stabilityInitial-2 -->
<id value="b664977d-799d-a1ce-928a-5def2a9955be"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Specimen</b><a name="b664977d-799d-a1ce-928a-5def2a9955be"> </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 Specimen "b664977d-799d-a1ce-928a-5def2a9955be" </p><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>2020-12-02</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>
<!-- when sample first taken, before the timed periods start -->
<collection>
<collectedDateTime value="2020-12-02"/>
</collection>
<processing>
<description value="No storage"/>
</processing>
<processing>
<description value="25°C/60% RH"/>
</processing>
</Specimen>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:b664977d-799d-a1ce-928b-5def2a9955be"/>
<resource>
<Specimen>
<!-- stabilityInitial-3 -->
<id value="b664977d-799d-a1ce-928b-5def2a9955be"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Specimen</b><a name="b664977d-799d-a1ce-928b-5def2a9955be"> </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 Specimen "b664977d-799d-a1ce-928b-5def2a9955be" </p><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>2020-12-03</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>
<!-- when sample first taken, before the timed periods start -->
<collection>
<collectedDateTime value="2020-12-03"/>
</collection>
<processing>
<description value="No storage"/>
</processing>
<processing>
<description value="25°C/60% RH"/>
</processing>
</Specimen>
</resource>
</entry>
<!-- Section 11 - Stability Study - Results - Test Result - Long Term XYZ - Initial - on batch 1 -->
<entry>
<fullUrl value="urn:uuid:6fabbf78-9678-8030-485f-b149956308d5"/>
<resource>
<Observation>
<!-- id value="LongTerm25C-initial-1"/ -->
<!-- observation-test-result-longterm25c-initial-1 -->
<id value="6fabbf78-9678-8030-485f-b149956308d5"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="6fabbf78-9678-8030-485f-b149956308d5"> </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 Observation "6fabbf78-9678-8030-485f-b149956308d5" </p><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_4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90">See above (ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - Initial (XYZ) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>specimen</b>: <a href="#Specimen_b664977d-799d-a1ce-928a-5def2a9955bd">See above (Specimen/b664977d-799d-a1ce-928a-5def2a9955bd)</a></p><p><b>hasMember</b>: </p><ul><li><a name="LongTerm25C-initial-1-Description"> </a></li><li><a name="observation-test-result-lt25c-i1-degradation-imp1"> </a></li><li><a name="LongTerm25C-initial-1-Degradation-imp2"> </a></li><li><a name="LongTerm25C-initial-1-Degradation-imp3"> </a></li><li><a name="LongTerm25C-initial-1-Degradation-impUnspecified"> </a></li><li><a name="LongTerm25C-initial-1-Degradation-impTotal"> </a></li><li><a name="LongTerm25C-initial-1-Water"> </a></li><li><a name="LongTerm25C-initial-1-Microbiological"> </a></li><li><a name="LongTerm25C-initial-1-Uniformity"> </a></li></ul><blockquote><p/><p><a name="LongTerm25C-initial-1-Description"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p/><p><a name="observation-test-result-lt25c-i1-degradation-imp1"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.101 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm25C-initial-1-Degradation-imp2"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.201 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm25C-initial-1-Degradation-imp3"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.201 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm25C-initial-1-Degradation-impUnspecified"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: <0.101 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Degradation Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm25C-initial-1-Degradation-impTotal"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Degradation Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm25C-initial-1-Water"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_186eb33e-a01d-4252-166c-b5ba5e8a697c">See above (ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c)</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.1501 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name="LongTerm25C-initial-1-Microbiological"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p/><p><a name="LongTerm25C-initial-1-Uniformity"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8">See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-1-Description</b><a name="LongTerm25C-initial-1-Description"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774">ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #observation-test-result-lt25c-i1-degradation-imp1</b><a name="observation-test-result-lt25c-i1-degradation-imp1"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.101 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-1-Degradation-imp2</b><a name="LongTerm25C-initial-1-Degradation-imp2"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.201 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-1-Degradation-imp3</b><a name="LongTerm25C-initial-1-Degradation-imp3"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.201 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-1-Degradation-impUnspecified</b><a name="LongTerm25C-initial-1-Degradation-impUnspecified"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: <0.101 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Degradation Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-1-Degradation-impTotal</b><a name="LongTerm25C-initial-1-Degradation-impTotal"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Degradation Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-1-Water</b><a name="LongTerm25C-initial-1-Water"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_186eb33e-a01d-4252-166c-b5ba5e8a697c">ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.1501 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-1-Microbiological</b><a name="LongTerm25C-initial-1-Microbiological"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-1-Uniformity</b><a name="LongTerm25C-initial-1-Uniformity"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8">ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></div>
</text>
<contained>
<Observation>
<id value="LongTerm25C-initial-1-Description"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"/>
</meta>
<instantiatesReference>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<contained>
<Observation>
<id value="observation-test-result-lt25c-i1-degradation-imp1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"/>
</meta>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.101"/>
<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"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<!-- could have the code of an impurity substance, or could have an extension to point to it as a resource -->
<text value="Impurity 1"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-initial-1-Degradation-imp2"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"/>
</meta>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.201"/>
<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"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Impurity 2"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-initial-1-Degradation-imp3"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"/>
</meta>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.201"/>
<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"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Impurity 3"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-initial-1-Degradation-impUnspecified"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"/>
</meta>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.101"/>
<comparator value="<"/>
<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"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Any Unspecified Degradation Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-initial-1-Degradation-impTotal"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"/>
</meta>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</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"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Total Degradation Impurities"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-initial-1-Water"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"/>
</meta>
<instantiatesReference>
<!-- ObservationDefinition/Water -->
<reference
value="ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="WaterContent"/>
<display value="Water Content"/>
</coding>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.1501"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-initial-1-Microbiological"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"/>
</meta>
<instantiatesReference>
<!-- ObservationDefinition/Microbiological -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Microbiological Quality"/>
<display value="Microbiological Quality"/>
</coding>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-initial-1-Uniformity"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"/>
</meta>
<instantiatesReference>
<!-- ObservationDefinition/Uniformity -->
<reference
value="ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="uniformity-dosage"/>
<display value="Uniformity of dosage units (by weight)"/>
</coding>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>
<!-- ActivityDefinition/activitydefinition-test-drug-pq-ex1 -->
<reference
value="ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"/>
</valueReference>
</extension>
<status value="final"/>
<code>
<text value="Test Components - Long-term 25C etc - Initial (XYZ)"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<specimen>
<!-- Specimen/specimen-drug-pq-ex1 -->
<reference value="Specimen/b664977d-799d-a1ce-928a-5def2a9955bd"/>
</specimen>
<hasMember>
<reference value="#LongTerm25C-initial-1-Description"/>
</hasMember>
<hasMember>
<reference
value="#observation-test-result-lt25c-i1-degradation-imp1"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-initial-1-Degradation-imp2"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-initial-1-Degradation-imp3"/>
</hasMember>
<hasMember>
<reference
value="#LongTerm25C-initial-1-Degradation-impUnspecified"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-initial-1-Degradation-impTotal"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-initial-1-Water"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-initial-1-Microbiological"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-initial-1-Uniformity"/>
</hasMember>
</Observation>
</resource>
</entry>
<!-- Section 11 - Stability Study - Results - Test Result - Long Term XYZ - on batch 2 -->
<entry>
<fullUrl value="urn:uuid:74535cc6-5232-5ab5-81cf-167a480795e5"/>
<resource>
<Observation>
<!-- LongTerm25C-initial-2 -->
<id value="74535cc6-5232-5ab5-81cf-167a480795e5"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="74535cc6-5232-5ab5-81cf-167a480795e5"> </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 Observation "74535cc6-5232-5ab5-81cf-167a480795e5" </p></div><p><b>Triggered by</b>: <a href="#ActivityDefinition_4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90">See above (ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - Initial (XYZ) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>subject</b>: <a href="#Medication_8306cfc5-158f-1a53-a683-048b226060d9">See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>specimen</b>: <a href="#Specimen_b664977d-799d-a1ce-928a-5def2a9955be">See above (Specimen/b664977d-799d-a1ce-928a-5def2a9955be)</a></p><p><b>hasMember</b>: </p><ul><li><a name="LongTerm25C-initial-2-Description"> </a></li><li><a name="LongTerm25C-initial-2-Degradation"> </a></li><li><a name="LongTerm25C-initial-2-Microbiological"> </a></li><li><a name="LongTerm25C-initial-2-Uniformity"> </a></li></ul><blockquote><p/><p><a name="LongTerm25C-initial-2-Description"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="#Medication_8306cfc5-158f-1a53-a683-048b226060d9">See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p/><p><a name="LongTerm25C-initial-2-Degradation"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Medication_8306cfc5-158f-1a53-a683-048b226060d9">See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.1 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name="LongTerm25C-initial-2-Microbiological"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href="#Medication_8306cfc5-158f-1a53-a683-048b226060d9">See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies</p></blockquote><blockquote><p/><p><a name="LongTerm25C-initial-2-Uniformity"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8">See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href="#Medication_8306cfc5-158f-1a53-a683-048b226060d9">See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-2-Description</b><a name="LongTerm25C-initial-2-Description"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774">ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_8306cfc5-158f-1a53-a683-048b226060d9">Medication/8306cfc5-158f-1a53-a683-048b226060d9</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-2-Degradation</b><a name="LongTerm25C-initial-2-Degradation"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_8306cfc5-158f-1a53-a683-048b226060d9">Medication/8306cfc5-158f-1a53-a683-048b226060d9</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.1 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-2-Microbiological</b><a name="LongTerm25C-initial-2-Microbiological"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_8306cfc5-158f-1a53-a683-048b226060d9">Medication/8306cfc5-158f-1a53-a683-048b226060d9</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies</p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-2-Uniformity</b><a name="LongTerm25C-initial-2-Uniformity"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8">ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_8306cfc5-158f-1a53-a683-048b226060d9">Medication/8306cfc5-158f-1a53-a683-048b226060d9</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></div>
</text>
<contained>
<Observation>
<id value="LongTerm25C-initial-2-Description"/>
<instantiatesReference>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-2 -->
<reference
value="Medication/8306cfc5-158f-1a53-a683-048b226060d9"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-initial-2-Degradation"/>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-2 -->
<reference
value="Medication/8306cfc5-158f-1a53-a683-048b226060d9"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.1"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-initial-2-Microbiological"/>
<instantiatesReference>
<!-- ObservationDefinition/Microbiological -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Microbiological Quality"/>
<display value="Microbiological Quality"/>
</coding>
</code>
<subject>
<!-- Medication/medication-actual-batch-2 -->
<reference
value="Medication/8306cfc5-158f-1a53-a683-048b226060d9"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueString value="Complies"/>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-initial-2-Uniformity"/>
<instantiatesReference>
<!-- ObservationDefinition/Uniformity -->
<reference
value="ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="uniformity-dosage"/>
<display value="Uniformity of dosage units (by weight)"/>
</coding>
</code>
<subject>
<!-- Medication/medication-actual-batch-2 -->
<reference
value="Medication/8306cfc5-158f-1a53-a683-048b226060d9"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<!-- use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan
that would mean using sub-ActivityDefintions probably -->
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>
<!-- ActivityDefinition/activitydefinition-test-drug-pq-ex1 -->
<reference
value="ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"/>
</valueReference>
</extension>
<status value="final"/>
<code>
<text value="Test Components - Long-term 25C etc - Initial (XYZ)"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-2 -->
<reference value="Medication/8306cfc5-158f-1a53-a683-048b226060d9"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<specimen>
<!-- Specimen/stabilityInitial-2 -->
<reference value="Specimen/b664977d-799d-a1ce-928a-5def2a9955be"/>
</specimen>
<hasMember>
<reference value="#LongTerm25C-initial-2-Description"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-initial-2-Degradation"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-initial-2-Microbiological"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-initial-2-Uniformity"/>
</hasMember>
</Observation>
</resource>
</entry>
<!-- Section 11 - Stability Study - Results - Test Result - Long Term XYZ - on batch 3 -->
<entry>
<fullUrl value="urn:uuid:8bf75da1-9221-66fe-6725-c64cb45a57e6"/>
<resource>
<Observation>
<!-- LongTerm25C-initial-3 -->
<id value="8bf75da1-9221-66fe-6725-c64cb45a57e6"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="8bf75da1-9221-66fe-6725-c64cb45a57e6"> </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 Observation "8bf75da1-9221-66fe-6725-c64cb45a57e6" </p></div><p><b>Triggered by</b>: <a href="#ActivityDefinition_4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90">See above (ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - Initial (XYZ) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>subject</b>: <a href="#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b">See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>specimen</b>: <a href="#Specimen_b664977d-799d-a1ce-928b-5def2a9955be">See above (Specimen/b664977d-799d-a1ce-928b-5def2a9955be)</a></p><p><b>hasMember</b>: </p><ul><li><a name="LongTerm25C-initial-3-Description"> </a></li><li><a name="LongTerm25C-initial-3-Degradation"> </a></li><li><a name="LongTerm25C-initial-3-Microbiological"> </a></li><li><a name="LongTerm25C-initial-3-Uniformity"> </a></li></ul><blockquote><p/><p><a name="LongTerm25C-initial-3-Description"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b">See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p/><p><a name="LongTerm25C-initial-3-Degradation"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b">See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.1 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name="LongTerm25C-initial-3-Microbiological"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href="#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b">See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p/><p><a name="LongTerm25C-initial-3-Uniformity"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8">See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href="#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b">See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-3-Description</b><a name="LongTerm25C-initial-3-Description"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774">ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b">Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-3-Degradation</b><a name="LongTerm25C-initial-3-Degradation"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b">Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.1 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-3-Microbiological</b><a name="LongTerm25C-initial-3-Microbiological"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b">Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-3-Uniformity</b><a name="LongTerm25C-initial-3-Uniformity"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8">ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b">Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></div>
</text>
<contained>
<Observation>
<id value="LongTerm25C-initial-3-Description"/>
<instantiatesReference>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-3 -->
<reference
value="Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-initial-3-Degradation"/>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-3 -->
<reference
value="Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.1"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-initial-3-Microbiological"/>
<instantiatesReference>
<!-- ObservationDefinition/Microbiological -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Microbiological Quality"/>
<display value="Microbiological Quality"/>
</coding>
</code>
<subject>
<!-- Medication/medication-actual-batch-3 -->
<reference
value="Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-initial-3-Uniformity"/>
<instantiatesReference>
<!-- ObservationDefinition/Uniformity -->
<reference
value="ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="uniformity-dosage"/>
<display value="Uniformity of dosage units (by weight)"/>
</coding>
</code>
<subject>
<!-- Medication/medication-actual-batch-3 -->
<reference
value="Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<!-- use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan
that would mean using sub-ActivityDefintions probably -->
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>
<!-- ActivityDefinition/activitydefinition-test-drug-pq-ex1 -->
<reference
value="ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"/>
</valueReference>
</extension>
<status value="final"/>
<code>
<text value="Test Components - Long-term 25C etc - Initial (XYZ)"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-3 -->
<reference value="Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<specimen>
<!-- Specimen/stabilityInitial-3 -->
<reference value="Specimen/b664977d-799d-a1ce-928b-5def2a9955be"/>
</specimen>
<hasMember>
<reference value="#LongTerm25C-initial-3-Description"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-initial-3-Degradation"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-initial-3-Microbiological"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-initial-3-Uniformity"/>
</hasMember>
</Observation>
</resource>
</entry>
<!-- specimen -->
<entry>
<fullUrl value="urn:uuid:18826818-10c4-972c-618e-01694ff06c78"/>
<resource>
<Specimen>
<!-- stability18months-1 -->
<id value="18826818-10c4-972c-618e-01694ff06c78"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Specimen</b><a name="18826818-10c4-972c-618e-01694ff06c78"> </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 Specimen "18826818-10c4-972c-618e-01694ff06c78" </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>: Store for 18 months</p><p><b>time</b>: 2020-12 --> 2022-06</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 25°C/60% RH</p></blockquote></div>
</text>
<!-- when sample first taken, before the timed periods start -->
<collection>
<collectedDateTime value="2020-12-01"/>
</collection>
<processing>
<description value="Store for 18 months"/>
<!-- 18 months -->
<timePeriod>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq">
<valueDuration>
<value value="18"/>
<unit value="month"/>
</valueDuration>
</extension>
<start value="2020-12"/>
<end value="2022-06"/>
</timePeriod>
</processing>
<processing>
<description value="25°C/60% RH"/>
</processing>
</Specimen>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:18826818-10c4-972c-618e-01694ff06c88"/>
<resource>
<Specimen>
<!-- stability18months-2 -->
<id value="18826818-10c4-972c-618e-01694ff06c88"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Specimen</b><a name="18826818-10c4-972c-618e-01694ff06c88"> </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 Specimen "18826818-10c4-972c-618e-01694ff06c88" </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>2020-12-02</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: Store for 18 months</p><p><b>time</b>: 2020-12 --> 2022-06</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 25°C/60% RH</p></blockquote></div>
</text>
<!-- when sample first taken, before the timed periods start -->
<collection>
<collectedDateTime value="2020-12-02"/>
</collection>
<processing>
<description value="Store for 18 months"/>
<!-- 18 months -->
<timePeriod>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq">
<valueDuration>
<value value="18"/>
<unit value="month"/>
</valueDuration>
</extension>
<start value="2020-12"/>
<end value="2022-06"/>
</timePeriod>
</processing>
<processing>
<description value="25°C/60% RH"/>
</processing>
</Specimen>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:18826818-10c4-972c-618e-01694ff06c89"/>
<resource>
<Specimen>
<!-- stability18months-3 -->
<id value="18826818-10c4-972c-618e-01694ff06c89"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Specimen</b><a name="18826818-10c4-972c-618e-01694ff06c89"> </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 Specimen "18826818-10c4-972c-618e-01694ff06c89" </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>2020-12-03</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: Store for 18 months</p><p><b>time</b>: 2020-12 --> 2022-06</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 25°C/60% RH</p></blockquote></div>
</text>
<!-- when sample first taken, before the timed periods start -->
<collection>
<collectedDateTime value="2020-12-03"/>
</collection>
<processing>
<description value="Store for 18 months"/>
<!-- 18 months -->
<timePeriod>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq">
<valueDuration>
<value value="18"/>
<unit value="month"/>
</valueDuration>
</extension>
<start value="2020-12"/>
<end value="2022-06"/>
</timePeriod>
</processing>
<processing>
<description value="25°C/60% RH"/>
</processing>
</Specimen>
</resource>
</entry>
<!-- Section 11 - Stability Study - Results - Test Result - Long Term XY - 18M - on batch 1 -->
<entry>
<fullUrl value="urn:uuid:e803ad6d-0cb3-87dd-6af1-4b88c654a47c"/>
<resource>
<Observation>
<!-- LongTerm25C-18m-1 -->
<id value="e803ad6d-0cb3-87dd-6af1-4b88c654a47c"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="e803ad6d-0cb3-87dd-6af1-4b88c654a47c"> </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 Observation "e803ad6d-0cb3-87dd-6af1-4b88c654a47c" </p></div><p><b>Triggered by</b>: <a href="#ActivityDefinition_ce2df6ab-5087-435c-35cb-a84572e756a2">See above (ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - 18 months (XY) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>specimen</b>: <a href="#Specimen_18826818-10c4-972c-618e-01694ff06c78">See above (Specimen/18826818-10c4-972c-618e-01694ff06c78)</a></p><p><b>hasMember</b>: </p><ul><li><a name="LongTerm25C-18m-1-Description"> </a></li><li><a name="LongTerm25C-18m-1-Degradation-imp1"> </a></li><li><a name="LongTerm25C-18m-1-Degradation-imp2"> </a></li><li><a name="LongTerm25C-18m-1-Degradation-imp3"> </a></li><li><a name="LongTerm25C-18m-1-Degradation-impUnspecified"> </a></li><li><a name="LongTerm25C-18m-1-Degradation-impTotal"> </a></li><li><a name="LongTerm25C-18m-1-Water"> </a></li><li><a name="LongTerm25C-18m-1-Microbiological"> </a></li><li><a name="LongTerm25C-18m-1-Uniformity"> </a></li></ul><blockquote><p/><p><a name="LongTerm25C-18m-1-Description"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p/><p><a name="LongTerm25C-18m-1-Degradation-imp1"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.118 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm25C-18m-1-Degradation-imp2"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.218 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm25C-18m-1-Degradation-imp3"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.218 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm25C-18m-1-Degradation-impUnspecified"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: <0.118 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Degradation Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm25C-18m-1-Degradation-impTotal"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.818 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Degradation Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="LongTerm25C-18m-1-Water"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_186eb33e-a01d-4252-166c-b5ba5e8a697c">See above (ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c)</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.1518 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name="LongTerm25C-18m-1-Microbiological"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies</p></blockquote><blockquote><p/><p><a name="LongTerm25C-18m-1-Uniformity"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8">See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Description</b><a name="LongTerm25C-18m-1-Description"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774">ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-imp1</b><a name="LongTerm25C-18m-1-Degradation-imp1"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.118 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-imp2</b><a name="LongTerm25C-18m-1-Degradation-imp2"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.218 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-imp3</b><a name="LongTerm25C-18m-1-Degradation-imp3"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.218 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-impUnspecified</b><a name="LongTerm25C-18m-1-Degradation-impUnspecified"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: <0.118 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Degradation Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-impTotal</b><a name="LongTerm25C-18m-1-Degradation-impTotal"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.818 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Degradation Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Water</b><a name="LongTerm25C-18m-1-Water"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_186eb33e-a01d-4252-166c-b5ba5e8a697c">ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.1518 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Microbiological</b><a name="LongTerm25C-18m-1-Microbiological"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies</p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Uniformity</b><a name="LongTerm25C-18m-1-Uniformity"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8">ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></div>
</text>
<contained>
<Observation>
<id value="LongTerm25C-18m-1-Description"/>
<instantiatesReference>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-18m-1-Degradation-imp1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"/>
</meta>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.118"/>
<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"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<!-- could have the code of an impurity substance, or could have an extension to point to it as a resource -->
<text value="Impurity 1"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-18m-1-Degradation-imp2"/>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.218"/>
<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"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Impurity 2"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-18m-1-Degradation-imp3"/>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.218"/>
<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"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Impurity 3"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-18m-1-Degradation-impUnspecified"/>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.118"/>
<comparator value="<"/>
<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"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Any Unspecified Degradation Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-18m-1-Degradation-impTotal"/>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.818"/>
<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"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Total Degradation Impurities"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-18m-1-Water"/>
<instantiatesReference>
<!-- ObservationDefinition/Water -->
<reference
value="ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="WaterContent"/>
<display value="Water Content"/>
</coding>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.1518"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-18m-1-Microbiological"/>
<instantiatesReference>
<!-- ObservationDefinition/Microbiological -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Microbiological Quality"/>
<display value="Microbiological Quality"/>
</coding>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueString value="Complies"/>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-18m-1-Uniformity"/>
<instantiatesReference>
<!-- ObservationDefinition/Uniformity -->
<reference
value="ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="uniformity-dosage"/>
<display value="Uniformity of dosage units (by weight)"/>
</coding>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<!-- use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan
that would mean using sub-ActivityDefintions probably -->
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>
<!-- ActivityDefinition/activityLongTerm25XY-18 -->
<reference
value="ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2"/>
</valueReference>
</extension>
<status value="final"/>
<code>
<text value="Test Components - Long-term 25C etc - 18 months (XY)"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<specimen>
<!-- Specimen/stability18months-1 -->
<reference value="Specimen/18826818-10c4-972c-618e-01694ff06c78"/>
</specimen>
<hasMember>
<reference value="#LongTerm25C-18m-1-Description"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-18m-1-Degradation-imp1"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-18m-1-Degradation-imp2"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-18m-1-Degradation-imp3"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-18m-1-Degradation-impUnspecified"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-18m-1-Degradation-impTotal"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-18m-1-Water"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-18m-1-Microbiological"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-18m-1-Uniformity"/>
</hasMember>
</Observation>
</resource>
</entry>
<!-- Section 11 - Stability Study - Results - Test Result - Long Term XY - 18M - on batch 2 -->
<entry>
<fullUrl value="urn:uuid:3519f84a-2889-90a0-a6b7-ff2f1be66a73"/>
<resource>
<Observation>
<!-- LongTerm25C-18m-2 -->
<id value="3519f84a-2889-90a0-a6b7-ff2f1be66a73"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="3519f84a-2889-90a0-a6b7-ff2f1be66a73"> </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 Observation "3519f84a-2889-90a0-a6b7-ff2f1be66a73" </p></div><p><b>Triggered by</b>: <a href="#ActivityDefinition_ce2df6ab-5087-435c-35cb-a84572e756a2">See above (ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - 18 months (XY) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>subject</b>: <a href="#Medication_8306cfc5-158f-1a53-a683-048b226060d9">See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>specimen</b>: <a href="#Specimen_18826818-10c4-972c-618e-01694ff06c88">See above (Specimen/18826818-10c4-972c-618e-01694ff06c88)</a></p><p><b>hasMember</b>: </p><ul><li><a name="LongTerm25C-18m-2-Description"> </a></li><li><a name="LongTerm25C-18m-2-Microbiological"> </a></li></ul><blockquote><p/><p><a name="LongTerm25C-18m-2-Description"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="#Medication_8306cfc5-158f-1a53-a683-048b226060d9">See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p/><p><a name="LongTerm25C-18m-2-Microbiological"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href="#Medication_8306cfc5-158f-1a53-a683-048b226060d9">See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Does not comply</p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-2-Description</b><a name="LongTerm25C-18m-2-Description"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774">ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_8306cfc5-158f-1a53-a683-048b226060d9">Medication/8306cfc5-158f-1a53-a683-048b226060d9</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-2-Microbiological</b><a name="LongTerm25C-18m-2-Microbiological"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_8306cfc5-158f-1a53-a683-048b226060d9">Medication/8306cfc5-158f-1a53-a683-048b226060d9</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Does not comply</p></blockquote></div>
</text>
<contained>
<Observation>
<id value="LongTerm25C-18m-2-Description"/>
<instantiatesReference>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-2 -->
<reference
value="Medication/8306cfc5-158f-1a53-a683-048b226060d9"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-18m-2-Microbiological"/>
<instantiatesReference>
<!-- ObservationDefinition/Microbiological -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Microbiological Quality"/>
<display value="Microbiological Quality"/>
</coding>
</code>
<subject>
<!-- Medication/medication-actual-batch-2 -->
<reference
value="Medication/8306cfc5-158f-1a53-a683-048b226060d9"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueString value="Does not comply"/>
</Observation>
</contained>
<!-- use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan
that would mean using sub-ActivityDefintions probably -->
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>
<!-- ActivityDefinition/activityLongTerm25XY-18 -->
<reference
value="ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2"/>
</valueReference>
</extension>
<status value="final"/>
<code>
<text value="Test Components - Long-term 25C etc - 18 months (XY)"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-2 -->
<reference value="Medication/8306cfc5-158f-1a53-a683-048b226060d9"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<specimen>
<!-- Specimen/stability18months-2 -->
<reference value="Specimen/18826818-10c4-972c-618e-01694ff06c88"/>
</specimen>
<hasMember>
<reference value="#LongTerm25C-18m-2-Description"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-18m-2-Microbiological"/>
</hasMember>
</Observation>
</resource>
</entry>
<!-- Section 11 - Stability Study - Results - Test Result - Long Term XY - 18M - on batch 3 -->
<entry>
<fullUrl value="urn:uuid:2ef362f1-0b65-3578-7f06-fbd74a24694a"/>
<resource>
<Observation>
<!-- LongTerm25C-18m-3 -->
<id value="2ef362f1-0b65-3578-7f06-fbd74a24694a"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="2ef362f1-0b65-3578-7f06-fbd74a24694a"> </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 Observation "2ef362f1-0b65-3578-7f06-fbd74a24694a" </p></div><p><b>Triggered by</b>: <a href="#ActivityDefinition_ce2df6ab-5087-435c-35cb-a84572e756a2">See above (ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - 18 months (XY) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>subject</b>: <a href="#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b">See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>specimen</b>: <a href="#Specimen_18826818-10c4-972c-618e-01694ff06c89">See above (Specimen/18826818-10c4-972c-618e-01694ff06c89)</a></p><p><b>hasMember</b>: </p><ul><li><a name="LongTerm25C-18m-3-Description"> </a></li><li><a name="LongTerm25C-18m-3-Microbiological"> </a></li></ul><blockquote><p/><p><a name="LongTerm25C-18m-3-Description"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b">See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p/><p><a name="LongTerm25C-18m-3-Microbiological"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href="#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b">See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Does not comply</p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-3-Description</b><a name="LongTerm25C-18m-3-Description"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774">ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b">Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-3-Microbiological</b><a name="LongTerm25C-18m-3-Microbiological"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b">Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Does not comply</p></blockquote></div>
</text>
<contained>
<Observation>
<id value="LongTerm25C-18m-3-Description"/>
<instantiatesReference>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-3 -->
<reference
value="Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<contained>
<Observation>
<id value="LongTerm25C-18m-3-Microbiological"/>
<instantiatesReference>
<!-- ObservationDefinition/Microbiological -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Microbiological Quality"/>
<display value="Microbiological Quality"/>
</coding>
</code>
<subject>
<!-- Medication/medication-actual-batch-3 -->
<reference
value="Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueString value="Does not comply"/>
</Observation>
</contained>
<!-- use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan
that would mean using sub-ActivityDefintions probably -->
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>
<!-- ActivityDefinition/activityLongTerm25XY-18 -->
<reference
value="ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2"/>
</valueReference>
</extension>
<status value="final"/>
<code>
<text value="Test Components - Long-term 25C etc - 18 months (XY)"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-3 -->
<reference value="Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<specimen>
<!-- Specimen/stability18months-3 -->
<reference value="Specimen/18826818-10c4-972c-618e-01694ff06c89"/>
</specimen>
<hasMember>
<reference value="#LongTerm25C-18m-3-Description"/>
</hasMember>
<hasMember>
<reference value="#LongTerm25C-18m-3-Microbiological"/>
</hasMember>
</Observation>
</resource>
</entry>
<!-- specimen -->
<entry>
<fullUrl value="urn:uuid:8a7771db-5cc0-33f8-966a-b2f792bf5785"/>
<resource>
<Specimen>
<!-- stabilityInitialAcc-3 -->
<id value="8a7771db-5cc0-33f8-966a-b2f792bf5785"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Specimen</b><a name="8a7771db-5cc0-33f8-966a-b2f792bf5785"> </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 Specimen "8a7771db-5cc0-33f8-966a-b2f792bf5785" </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>: Store for 3 months</p><p><b>time</b>: 2020-12 --> 2021-03</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 40°C/75% RH</p></blockquote></div>
</text>
<!-- when sample first taken, before the timed periods start -->
<collection>
<collectedDateTime value="2020-12-01"/>
</collection>
<processing>
<description value="Store for 3 months"/>
<!-- 3 months -->
<timePeriod>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq">
<valueDuration>
<value value="18"/>
<unit value="month"/>
</valueDuration>
</extension>
<start value="2020-12"/>
<end value="2021-03"/>
</timePeriod>
</processing>
<processing>
<description value="40°C/75% RH"/>
</processing>
</Specimen>
</resource>
</entry>
<!-- Section 11 - Stability Study - Results - Test Result - Accelerated XYZ - Initial - on batch 1 -->
<entry>
<fullUrl value="urn:uuid:72e0640b-094b-909e-5268-3dee92af4bbd"/>
<resource>
<Observation>
<!-- Accelerated40C-3-1 -->
<id value="72e0640b-094b-909e-5268-3dee92af4bbd"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="72e0640b-094b-909e-5268-3dee92af4bbd"> </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 Observation "72e0640b-094b-909e-5268-3dee92af4bbd" </p></div><p><b>Triggered by</b>: <a href="#ActivityDefinition_096e3f32-798e-6792-76ad-4ea783521c50">See above (ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Accelerated 40C etc - 3 Months (X) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>specimen</b>: <a href="#Specimen_8a7771db-5cc0-33f8-966a-b2f792bf5785">See above (Specimen/8a7771db-5cc0-33f8-966a-b2f792bf5785)</a></p><p><b>hasMember</b>: </p><ul><li><a name="Accelerated40C-3-1-Description"> </a></li><li><a name="Accelerated40C-3-1-Degradation-imp1"> </a></li><li><a name="Accelerated40C-3-1-Degradation-imp2"> </a></li><li><a name="Accelerated40C-3-1-Degradation-imp3"> </a></li><li><a name="Accelerated40C-3-1-Degradation-impUnspecified"> </a></li><li><a name="Accelerated40C-3-1-Degradation-impTotal"> </a></li><li><a name="Accelerated40C-3-1-Water"> </a></li><li><a name="Accelerated40C-3-1-Microbiological"> </a></li><li><a name="Accelerated40C-3-1-Uniformity"> </a></li></ul><blockquote><p/><p><a name="Accelerated40C-3-1-Description"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p/><p><a name="Accelerated40C-3-1-Degradation-imp1"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.143 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="Accelerated40C-3-1-Degradation-imp2"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.243 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="Accelerated40C-3-1-Degradation-imp3"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.201 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="Accelerated40C-3-1-Degradation-impUnspecified"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: <0.101 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Degradation Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="Accelerated40C-3-1-Degradation-impTotal"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Degradation Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name="Accelerated40C-3-1-Water"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_186eb33e-a01d-4252-166c-b5ba5e8a697c">See above (ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c)</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.1501 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name="Accelerated40C-3-1-Microbiological"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p/><p><a name="Accelerated40C-3-1-Uniformity"> </a></p><p><b>instantiates</b>: <a href="#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8">See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href="#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Description</b><a name="Accelerated40C-3-1-Description"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774">ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Degradation-imp1</b><a name="Accelerated40C-3-1-Degradation-imp1"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.143 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Degradation-imp2</b><a name="Accelerated40C-3-1-Degradation-imp2"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.243 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Degradation-imp3</b><a name="Accelerated40C-3-1-Degradation-imp3"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.201 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Degradation-impUnspecified</b><a name="Accelerated40C-3-1-Degradation-impUnspecified"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: <0.101 % 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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Degradation Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Degradation-impTotal</b><a name="Accelerated40C-3-1-Degradation-impTotal"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</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>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Degradation Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Water</b><a name="Accelerated40C-3-1-Water"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_186eb33e-a01d-4252-166c-b5ba5e8a697c">ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.1501 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Microbiological</b><a name="Accelerated40C-3-1-Microbiological"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Uniformity</b><a name="Accelerated40C-3-1-Uniformity"> </a></p><p><b>instantiates</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8">ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href="Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></div>
</text>
<contained>
<Observation>
<id value="Accelerated40C-3-1-Description"/>
<instantiatesReference>
<!-- ObservationDefinition/Description -->
<reference
value="ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<contained>
<Observation>
<id value="Accelerated40C-3-1-Degradation-imp1"/>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.143"/>
<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"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<!-- could have the code of an impurity substance, or could have an extension to point to it as a resource -->
<text value="Impurity 1"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="Accelerated40C-3-1-Degradation-imp2"/>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.243"/>
<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"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<!-- could have the code of an impurity substance, or could have an extension to point to it as a resource -->
<text value="Impurity 2"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="Accelerated40C-3-1-Degradation-imp3"/>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.201"/>
<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"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Impurity 3"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="Accelerated40C-3-1-Degradation-impUnspecified"/>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.101"/>
<comparator value="<"/>
<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"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Any Unspecified Degradation Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="Accelerated40C-3-1-Degradation-impTotal"/>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</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"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Total Degradation Impurities"/>
</valueCodeableConcept>
</component>
</Observation>
</contained>
<contained>
<Observation>
<id value="Accelerated40C-3-1-Water"/>
<instantiatesReference>
<!-- ObservationDefinition/Water -->
<reference
value="ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="WaterContent"/>
<display value="Water Content"/>
</coding>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.1501"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</contained>
<contained>
<Observation>
<id value="Accelerated40C-3-1-Microbiological"/>
<instantiatesReference>
<!-- ObservationDefinition/Microbiological -->
<reference
value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Microbiological Quality"/>
<display value="Microbiological Quality"/>
</coding>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<contained>
<Observation>
<id value="Accelerated40C-3-1-Uniformity"/>
<instantiatesReference>
<!-- ObservationDefinition/Uniformity -->
<reference
value="ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="uniformity-dosage"/>
<display value="Uniformity of dosage units (by weight)"/>
</coding>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference
value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained>
<!-- use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan
that would mean using sub-ActivityDefintions probably -->
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>
<!-- ActivityDefinition/activityAccelerated40X-3 -->
<reference
value="ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50"/>
</valueReference>
</extension>
<status value="final"/>
<code>
<text value="Test Components - Accelerated 40C etc - 3 Months (X)"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/tester -->
<reference
value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<specimen>
<!-- Specimen/stabilityInitialAcc-3 -->
<reference value="Specimen/8a7771db-5cc0-33f8-966a-b2f792bf5785"/>
</specimen>
<hasMember>
<reference value="#Accelerated40C-3-1-Description"/>
</hasMember>
<hasMember>
<reference value="#Accelerated40C-3-1-Degradation-imp1"/>
</hasMember>
<hasMember>
<reference value="#Accelerated40C-3-1-Degradation-imp2"/>
</hasMember>
<hasMember>
<reference value="#Accelerated40C-3-1-Degradation-imp3"/>
</hasMember>
<hasMember>
<reference value="#Accelerated40C-3-1-Degradation-impUnspecified"/>
</hasMember>
<hasMember>
<reference value="#Accelerated40C-3-1-Degradation-impTotal"/>
</hasMember>
<hasMember>
<reference value="#Accelerated40C-3-1-Water"/>
</hasMember>
<hasMember>
<reference value="#Accelerated40C-3-1-Microbiological"/>
</hasMember>
<hasMember>
<reference value="#Accelerated40C-3-1-Uniformity"/>
</hasMember>
</Observation>
</resource>
</entry>
<!-- Section 8 - Batch or Lot Information (batch 1 of 3) -->
<entry>
<fullUrl value="urn:uuid:7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
<resource>
<Medication>
<!-- <id value="medication-actual-batch"/> -->
<!-- medication-batch-information-drug-pq-ex1 -->
<id value="7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Medication-batch-information-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Medication</b><a name="7ef62d57-7cc6-9211-66d6-abc7e096093c"> </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 Medication "7ef62d57-7cc6-9211-66d6-abc7e096093c" </p><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 style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>Batches</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style="display: none">*</td><td>, , , , , </td><td>33445</td></tr></table></div>
</text>
<code>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq">
<valueReference>
<!-- todo consider change this be the MID? -->
<!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1 -->
<reference
value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
</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>
<!-- could also be C185328 Stability Study? -->
<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/organization-drug-pq-ex1 -->
<reference
value="Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c"/>
</valueReference>
</extension>
<extension url="container">
<extension url="type">
<valueCodeableConcept>
<text value="100 cc HDPE Bottle 2 g desiccant"/>
</valueCodeableConcept>
</extension>
<extension url="closureSystemDescription">
<valueString value="Standard closure"/>
</extension>
</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-substance-batch-pq">
<valueReference>
<!-- Substance/substance-dxpq-ex1 -->
<reference
value="Substance/fc078762-81c5-5656-9744-13c7ad1e595b"/>
</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>
<!-- Organization/packaging -->
<reference
value="Organization/2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc"/>
</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>
<lotNumber value="33445"/>
</batch>
</Medication>
</resource>
</entry>
<!-- Section 8 - Batch or Lot Information (another batch 2 of 3) -->
<entry>
<fullUrl value="urn:uuid:8306cfc5-158f-1a53-a683-048b226060d9"/>
<resource>
<Medication>
<!-- medication-actual-batch-2 -->
<id value="8306cfc5-158f-1a53-a683-048b226060d9"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Medication</b><a name="8306cfc5-158f-1a53-a683-048b226060d9"> </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 Medication "8306cfc5-158f-1a53-a683-048b226060d9" </p></div><p><b>code</b>: <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>Batches</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style="display: none">*</td><td>, , , , , </td><td>33446</td></tr></table></div>
</text>
<code>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq">
<valueReference>
<!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1 -->
<reference
value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
</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="100050"/>
<unit value="tablets"/>
</valueQuantity>
</extension>
<extension url="batchUtilization">
<valueCodeableConcept>
<!-- could also be C185328 Stability Study? -->
<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/manufacturer -->
<reference
value="Organization/033ce81d-5f0d-7a3e-93d3-fc64e122a1fd"/>
</valueReference>
</extension>
<extension url="container">
<extension url="type">
<valueCodeableConcept>
<text value="100 cc HDPE Bottle 2 g desiccant"/>
</valueCodeableConcept>
</extension>
</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-substance-batch-pq">
<valueReference>
<!-- Substance/actual-batch-substance-2 -->
<reference
value="Substance/cb31d747-2338-88d5-342c-8e9c097e4dad"/>
</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>
<!-- Organization/packaging -->
<reference
value="Organization/2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc"/>
</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>
<lotNumber value="33446"/>
</batch>
</Medication>
</resource>
</entry>
<!-- Section 8 - Batch or Lot Information (another batch 3 of 3) -->
<entry>
<fullUrl value="urn:uuid:f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"/>
<resource>
<Medication>
<!-- medication-actual-batch-3 -->
<id value="f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Medication</b><a name="f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"> </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 Medication "f54d4666-7ae3-4e30-8c5a-6d13838c4f3b" </p></div><p><b>code</b>: <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>Batches</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style="display: none">*</td><td>, , , , , </td><td>33447</td></tr></table></div>
</text>
<code>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq">
<valueReference>
<!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1 -->
<reference
value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
</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="100125"/>
<unit value="tablets"/>
</valueQuantity>
</extension>
<extension url="batchUtilization">
<valueCodeableConcept>
<!-- could also be C185328 Stability Study? -->
<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/manufacturer -->
<reference
value="Organization/033ce81d-5f0d-7a3e-93d3-fc64e122a1fd"/>
</valueReference>
</extension>
<extension url="container">
<extension url="type">
<valueCodeableConcept>
<text value="100 cc HDPE Bottle 2 g desiccant"/>
</valueCodeableConcept>
</extension>
</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-substance-batch-pq">
<valueReference>
<!-- Substance/actual-batch-substance-3 -->
<reference
value="Substance/1551f97b-6f6d-825e-1fb3-44b0b090808c"/>
</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>
<!-- Organization/packaging -->
<reference
value="Organization/2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc"/>
</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>
<lotNumber value="33447"/>
</batch>
</Medication>
</resource>
</entry>
<!-- Section 4.1 - Manufacturer -->
<entry>
<fullUrl value="urn:uuid:033ce81d-5f0d-7a3e-93d3-fc64e122a1fd"/>
<resource>
<Organization>
<!-- manufacturer -->
<id value="033ce81d-5f0d-7a3e-93d3-fc64e122a1fd"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="033ce81d-5f0d-7a3e-93d3-fc64e122a1fd"> </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 "033ce81d-5f0d-7a3e-93d3-fc64e122a1fd" </p></div><p><b>identifier</b>: id: 3010027650</p><p><b>name</b>: AAA Pharmaceutical, 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>681 Main Street Lumberton New Jersey 08048 USA </td></tr></table></div>
</text>
<identifier>
<!-- FDA establishment identifier -->
<system value="urn:oid:2.16.840.1.113883.4.82"/>
<value value="3010027650"/>
</identifier>
<name value="AAA Pharmaceutical, Inc."/>
<!-- contact>
<address></address>
</contact -->
<contact>
<address>
<!-- todo change to be contact/address -->
<line value="681 Main Street"/>
<city value="Lumberton"/>
<state value="New Jersey"/>
<postalCode value="08048"/>
<country value="USA"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc"/>
<resource>
<Organization>
<!-- packaging -->
<id value="2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc"> </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 "2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc" </p></div><p><b>name</b>: MySite</p></div>
</text>
<name value="MySite"/>
</Organization>
</resource>
</entry>
<!-- Section 4.2 - Testing Site -->
<entry>
<fullUrl value="urn:uuid:e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
<resource>
<Organization>
<!-- tester -->
<id value="e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="e3d2bc19-2f10-2b4d-1741-e4135fe612a9"> </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 "e3d2bc19-2f10-2b4d-1741-e4135fe612a9" </p></div><p><b>identifier</b>: id: 3007270600</p><p><b>name</b>: Advanced Analytical Testing Laboratories 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>30 Silverline Drive North Brunswick New Jersey 08902 USA </td></tr></table></div>
</text>
<!-- could also use assigner here, for #74 -->
<identifier>
<system value="urn:oid:2.16.840.1.113883.4.82"/>
<value value="3007270600"/>
</identifier>
<name value="Advanced Analytical Testing Laboratories Inc."/>
<contact>
<address>
<line value="30 Silverline Drive"/>
<city value="North Brunswick"/>
<state value="New Jersey"/>
<postalCode value="08902"/>
<country value="USA"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<!-- MedicinalProductDefinition - the main resource in any product scenario -->
<entry>
<fullUrl value="urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
<!-- Section 1.1 - DP Identification -->
<resource>
<MedicinalProductDefinition>
<!-- <id value="product"/> -->
<!-- medicinalproductdefinition-drug-product-pq-ex1 -->
<id value="a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: MedicinalProductDefinition</b><a name="a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"> </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 MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-MedicinalProductDefinition-drug-product-pq.html">MedicinalProductDefinition - Drug Product PQ</a></p></div><p><b>description</b>: Textual description of the product</p><p><b>combinedPharmaceuticalDoseForm</b>: Gastro-resistant tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (standardterms.edqm.eu#10225000)</span></p><p><b>route</b>: Oral use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (standardterms.edqm.eu#20053000)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Stelbat Tablets, 20mg</p><p><b>type</b>: Proprietary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-productNameType-local-pq.html">CodeSystem - Product Name Type</a>#Proprietary)</span></p><h3>Parts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Part</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>20mg</td><td>Strength part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-medicinal-product-name-part-type.html">Product Name Part Type</a>#StrengthPart)</span></td></tr></table></blockquote></div>
</text>
<description value="Textual description of the product"/>
<combinedPharmaceuticalDoseForm>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="10225000"/>
<display value="Gastro-resistant tablet"/>
</coding>
</combinedPharmaceuticalDoseForm>
<route>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="20053000"/>
<display value="Oral use"/>
</coding>
</route>
<name>
<productName value="Stelbat Tablets, 20mg"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-local-pq"/>
<code value="Proprietary"/>
<display value="Proprietary"/>
</coding>
</type>
<part>
<part value="20mg"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="StrengthPart"/>
<display value="Strength part"/>
</coding>
</type>
</part>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6"/>
<resource>
<Ingredient>
<!-- id value="productIngredient"/ -->
<!-- ingredient-drug-pq-ex1 -->
<id value="a0694a7a-aafa-4cbe-8135-c788a9a4d3d6"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Ingredient-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b><a name="a0694a7a-aafa-4cbe-8135-c788a9a4d3d6"> </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 Ingredient "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Ingredient-drug-pq.html">Ingredient - Drug Pq</a></p></div><p><b>status</b>: active</p><p><b>for</b>: <a href="#MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5">See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)</a></p><p><b>role</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-ingredient-role.html">Ingredient Role</a>#100000072072)</span></p><blockquote><p><b>substance</b></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_57a9af63-315d-1585-a261-0e337b289390">See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)</a></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>
<!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1 -->
<reference
value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
</for>
<role>
<coding>
<system value="http://hl7.org/fhir/ingredient-role"/>
<code value="100000072072"/>
<display value="Active"/>
</coding>
</role>
<substance>
<code>
<reference>
<!-- SubstanceDefinition/substancedefinition-component-substance-drug-pq-ex1 -->
<reference
value="SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390"/>
</reference>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:57a9af63-315d-1585-a261-0e337b289390"/>
<resource>
<SubstanceDefinition>
<!-- substancedefinition-component-substance-drug-pq-ex1 -->
<id value="57a9af63-315d-1585-a261-0e337b289390"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="57a9af63-315d-1585-a261-0e337b289390"> </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 "57a9af63-315d-1585-a261-0e337b289390" </p><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>manufacturer</b>: <a href="#Organization_49d2f0c0-4b28-9271-8aaf-2996a8b9739c">See above (Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c)</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/organization-drug-pq-ex1 -->
<reference
value="Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c"/>
</manufacturer>
<name>
<name value="Stelbatolol"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:49d2f0c0-4b28-9271-8aaf-2996a8b9739c"/>
<resource>
<Organization>
<!-- id value="substance-manufacturer"/ -->
<!-- organization-drug-pq-ex1 -->
<id value="49d2f0c0-4b28-9271-8aaf-2996a8b9739c"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="49d2f0c0-4b28-9271-8aaf-2996a8b9739c"> </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 "49d2f0c0-4b28-9271-8aaf-2996a8b9739c" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Organization-drug-pq.html">Organization - Drug PQ</a></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:fc078762-81c5-5656-9744-13c7ad1e595b"/>
<resource>
<Substance>
<!-- <id value="actual-batch-substance"/> -->
<!-- substance-dxpq-ex1 -->
<id value="fc078762-81c5-5656-9744-13c7ad1e595b"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Substance</b><a name="fc078762-81c5-5656-9744-13c7ad1e595b"> </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 "fc078762-81c5-5656-9744-13c7ad1e595b" </p><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><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2019-09-07</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 5 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Development <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>#C133991)</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href="#Organization_49d2f0c0-4b28-9271-8aaf-2996a8b9739c">See above (Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c)</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: 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_57a9af63-315d-1585-a261-0e337b289390">See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)</a></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>
<!-- Organization/organization-drug-pq-ex1 -->
<reference
value="Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c"/>
</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="CAT1"/>
</identifier>
<instance value="true"/>
<code>
<reference>
<!-- SubstanceDefinition/substancedefinition-component-substance-drug-pq-ex1 -->
<reference
value="SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390"/>
</reference>
</code>
</Substance>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:cb31d747-2338-88d5-342c-8e9c097e4dad"/>
<resource>
<Substance>
<!-- actual-batch-substance-2 -->
<id value="cb31d747-2338-88d5-342c-8e9c097e4dad"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Substance</b><a name="cb31d747-2338-88d5-342c-8e9c097e4dad"> </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 "cb31d747-2338-88d5-342c-8e9c097e4dad" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2019-09-07</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 5 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Development <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>#C133991)</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href="#Organization_49d2f0c0-4b28-9271-8aaf-2996a8b9739c">See above (Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c)</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_57a9af63-315d-1585-a261-0e337b289390">See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)</a></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>
<!-- Organization/organization-drug-pq-ex1 -->
<reference
value="Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c"/>
</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/substancedefinition-component-substance-drug-pq-ex1 -->
<reference
value="SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390"/>
</reference>
</code>
</Substance>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:1551f97b-6f6d-825e-1fb3-44b0b090808c"/>
<resource>
<Substance>
<!-- actual-batch-substance-3 -->
<id value="1551f97b-6f6d-825e-1fb3-44b0b090808c"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Substance</b><a name="1551f97b-6f6d-825e-1fb3-44b0b090808c"> </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 "1551f97b-6f6d-825e-1fb3-44b0b090808c" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2019-09-07</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 5 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Development <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>#C133991)</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href="#Organization_49d2f0c0-4b28-9271-8aaf-2996a8b9739c">See above (Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c)</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_57a9af63-315d-1585-a261-0e337b289390">See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)</a></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>
<!-- Organization/organization-drug-pq-ex1 -->
<reference
value="Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c"/>
</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/substancedefinition-component-substance-drug-pq-ex1 -->
<reference
value="SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390"/>
</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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