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 Process Validation -->
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundle-product-process-validation-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-process-validation-pq"/>
</meta>
<type value="collection"/>
<entry>
<fullUrl value="urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f"/>
<resource>
<PlanDefinition>
<!-- validationProtocol -->
<id value="2038e4c7-22b8-4c56-2d28-6c077648763f"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PlanDefinition</b><a name="2038e4c7-22b8-4c56-2d28-6c077648763f"> </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 "2038e4c7-22b8-4c56-2d28-6c077648763f" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f</code></p><p><b>title</b>: DP PROCESS VALIDATION</p><p><b>type</b>: Workflow Definition <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-plan-definition-type.html">PlanDefinitionType</a>#workflow-definition; <a href="CodeSystem-cs-planType-local-pq.html">CodeSystem - Plan Type</a>#process-validation "Process Validation")</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>: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...</p><blockquote><p><b>action</b></p><p><b>title</b>: Compounding Step</p><p><b>code</b>: Compounding Step <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-manufacturingStep-local-pq.html">CodeSystem - Manufacturing Step</a>#compounding)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: Compounding Steps</p><p><b>code</b>: Compounding <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></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></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Filling Steps</p><p><b>code</b>: Filling Step <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-manufacturingStep-local-pq.html">CodeSystem - Manufacturing Step</a>#filling)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: ???</p><p><b>code</b>: ??? <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></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><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Lyophilization Step</p><p><b>code</b>: Lyophilization Step <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-manufacturingStep-local-pq.html">CodeSystem - Manufacturing Step</a>#lyophilization)</span></p><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style="display: none">*</td><td>Conclusion <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><code>ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424</code></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><code>ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424</code></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><code>ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e</code></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><code>ObservationDefinition/32e29d22-5fcb-546e-24fd-52a4a4004467</code></td></tr><tr><td style="display: none">*</td><td>Homogeneity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><code>ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467</code></td></tr><tr><td style="display: none">*</td><td>Homogeneity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><code>ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467</code></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Release Step</p><p><b>code</b>: Release Step <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-manufacturingStep-local-pq.html">CodeSystem - Manufacturing Step</a>#release)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: ???</p><p><b>code</b>: ??? <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></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><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/2038e4c7-22b8-4c56-2d28-6c077648763f -->
<url
value="http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f"/>
<title value="DP PROCESS VALIDATION"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/plan-definition-type"/>
<code value="workflow-definition"/>
<display value="Workflow Definition"/>
</coding>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-planType-local-pq"/>
<code value="process-validation"/>
<display value="Process Validation"/>
</coding>
</type>
<status value="active"/>
<subjectReference>
<!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1 -->
<reference
value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
</subjectReference>
<description
value="Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies..."/>
<action>
<title value="Compounding Step"/>
<!-- text value="Overall set of actions"/ -->
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"/>
<code value="compounding"/>
<display value="Compounding Step"/>
</coding>
</code>
<action>
<!-- this level is not really needed here, could remove. But in the case where there are different timings, it is needed, so it is here for consistency -->
<title value="Compounding Steps"/>
<code>
<text value="Compounding"/>
</code>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/compoundingpHPre -->
<definitionCanonical
value="ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/compoundingpHPost -->
<definitionCanonical
value="ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/compoundingAssayPre -->
<definitionCanonical
value="ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/compoundingAssayPost -->
<definitionCanonical
value="ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73"/>
</action>
</action>
</action>
<action>
<title value="Filling Steps"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"/>
<code value="filling"/>
<display value="Filling Step"/>
</coding>
</code>
<action>
<title value="???"/>
<code>
<text value="???"/>
</code>
<action>
<code>
<text value="Conclusion"/>
</code>
<!-- ObservationDefinition/conclusion -->
<definitionCanonical
value="ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/TAMC -->
<definitionCanonical
value="ObservationDefinition/64505a3c-5034-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/TYMC -->
<definitionCanonical
value="ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/FillWeightAverage -->
<definitionCanonical
value="ObservationDefinition/64515a3c-5134-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/FillWeightTarget -->
<definitionCanonical
value="ObservationDefinition/64525a3c-5134-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/FillWeightAverageFromTarget -->
<definitionCanonical
value="ObservationDefinition/64515a3c-5134-448a-9c29-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/HoldTimeFiltrationToFilling -->
<definitionCanonical
value="ObservationDefinition/64515a3c-5234-448a-9c29-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/HoldTimeFilling -->
<definitionCanonical
value="ObservationDefinition/64515a3c-5334-448a-9c29-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/FilterIntegrity -->
<definitionCanonical
value="ObservationDefinition/64535a3c-5334-448a-9c29-938ce1958424"/>
</action>
</action>
</action>
<action>
<title value="Lyophilization Step"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"/>
<code value="lyophilization"/>
<display value="Lyophilization Step"/>
</coding>
</code>
<action>
<code>
<text value="Conclusion"/>
</code>
<!-- ObservationDefinition/LyophilizationConclusion -->
<definitionCanonical
value="ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/LyophilizerNumber -->
<definitionCanonical
value="ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/LyophilizationAssay -->
<definitionCanonical
value="ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/LyophilizationWater -->
<definitionCanonical
value="ObservationDefinition/32e29d22-5fcb-546e-24fd-52a4a4004467"/>
</action>
<action>
<code>
<text value="Homogeneity"/>
</code>
<!-- ObservationDefinition/LyophilizationWaterHomogeneity -->
<definitionCanonical
value="ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467"/>
</action>
<action>
<code>
<text value="Homogeneity"/>
</code>
<!-- ObservationDefinition/LyophilizationAssayHomogeneity -->
<definitionCanonical
value="ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467"/>
</action>
</action>
<action>
<title value="Release Step"/>
<!-- text value="Overall set of actions"/ -->
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"/>
<code value="release"/>
<display value="Release Step"/>
</coding>
</code>
<action>
<title value="???"/>
<code>
<text value="???"/>
</code>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/AppearanceProduct -->
<definitionCanonical
value="ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-47cb5b295e72"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/AppearanceLyophilized -->
<definitionCanonical
value="ObservationDefinition/fc07b5d5-9fe1-92c3-2d16-47cb5b295e72"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/AppearanceReconstituted -->
<definitionCanonical
value="ObservationDefinition/fc07b5d5-9fe1-92c3-2d06-47cb5b295e72"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Identification -->
<definitionCanonical
value="ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Assay -->
<definitionCanonical
value="ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Degradation -->
<definitionCanonical
value="ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Water -->
<definitionCanonical
value="ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/UniformityUSP -->
<definitionCanonical
value="ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d7"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/UniformityAcceptance -->
<definitionCanonical
value="ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d8"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/releasepH -->
<definitionCanonical
value="ObservationDefinition/fc17b5d6-9fe1-91c2-2d06-47cb5b295e72"/>
</action>
</action>
</action>
</PlanDefinition>
</resource>
</entry>
<!-- compounding step -->
<entry>
<fullUrl value="urn:uuid:fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"/>
<resource>
<ObservationDefinition>
<!-- compoundingpHPre -->
<id value="fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"> </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 "fc17b5d5-9fe1-91c2-2d06-47cb5b295e72" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72</code></p><p><b>title</b>: pH (adjustment of pre-clarification bulk solution)</p><p><b>status</b>: active</p><p><b>code</b>: pH (adjustment of pre-clarification bulk solution) <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>#pH (adjustment of pre-clarification bulk solution))</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>6.9-7.1 pH</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"/>
<title value="pH (adjustment of pre-clarification bulk solution)"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="pH (adjustment of pre-clarification bulk solution)"/>
<display
value="pH (adjustment of pre-clarification bulk solution)"/>
</coding>
<text value="pH (adjustment of pre-clarification bulk solution)"/>
</code>
<qualifiedValue>
<range>
<low>
<value value="6.9"/>
<unit value="pH"/>
<system value="http://unitsofmeasure.org"/>
<code value="pH"/>
</low>
<high>
<value value="7.1"/>
<unit value="pH"/>
<system value="http://unitsofmeasure.org"/>
<code value="pH"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"/>
<resource>
<ObservationDefinition>
<!-- compoundingpHPost -->
<id value="fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"> </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 "fc17b5d5-9fe1-91c2-2d06-47cb5b295e73" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73</code></p><p><b>title</b>: pH (post-dilution bulk solution)</p><p><b>status</b>: active</p><p><b>code</b>: pH (post-dilution bulk solution) <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>#pH (post-dilution bulk solution))</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>7.0-7.1 pH</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"/>
<title value="pH (post-dilution bulk solution)"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="pH (post-dilution bulk solution)"/>
<display value="pH (post-dilution bulk solution)"/>
</coding>
<text value="pH (post-dilution bulk solution)"/>
</code>
<qualifiedValue>
<range>
<low>
<value value="7.0"/>
<unit value="pH"/>
<system value="http://unitsofmeasure.org"/>
<code value="pH"/>
</low>
<high>
<value value="7.1"/>
<unit value="pH"/>
<system value="http://unitsofmeasure.org"/>
<code value="pH"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:fd17b5d5-9fe1-91c2-2d06-47cb5b295e72"/>
<resource>
<ObservationDefinition>
<!-- compoundingAssayPre -->
<id value="fd17b5d5-9fe1-91c2-2d06-47cb5b295e72"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="fd17b5d5-9fe1-91c2-2d06-47cb5b295e72"> </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 "fd17b5d5-9fe1-91c2-2d06-47cb5b295e72" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72</code></p><p><b>title</b>: Assay (pre-clarification filtration) (mg/mL)</p><p><b>status</b>: active</p><p><b>code</b>: Assay (pre-clarification filtration) (mg/mL) <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>#Assay (pre-clarification filtration) (mg/mL))</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>22-? mg/mL</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72"/>
<title value="Assay (pre-clarification filtration) (mg/mL)"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Assay (pre-clarification filtration) (mg/mL)"/>
<display value="Assay (pre-clarification filtration) (mg/mL)"/>
</coding>
<text value="Assay (pre-clarification filtration) (mg/mL)"/>
</code>
<qualifiedValue>
<range>
<!-- todo correct this and the others -->
<low>
<value value="22"/>
<unit value="mg/mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg/mL"/>
</low>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:fd17b5d5-9fe1-91c2-2d06-47cb5b295e73"/>
<resource>
<ObservationDefinition>
<!-- compoundingAssayPost -->
<id value="fd17b5d5-9fe1-91c2-2d06-47cb5b295e73"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="fd17b5d5-9fe1-91c2-2d06-47cb5b295e73"> </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 "fd17b5d5-9fe1-91c2-2d06-47cb5b295e73" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73</code></p><p><b>title</b>: Assay (Post dilution bulk solution) (mg/mL)</p><p><b>status</b>: active</p><p><b>code</b>: Assay (Post dilution bulk solution) (mg/mL) <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>#Assay (Post dilution bulk solution) (mg/mL))</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>20-21 mg/mL</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73"/>
<title value="Assay (Post dilution bulk solution) (mg/mL)"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Assay (Post dilution bulk solution) (mg/mL)"/>
<display value="Assay (Post dilution bulk solution) (mg/mL)"/>
</coding>
<text value="Assay (Post dilution bulk solution) (mg/mL)"/>
</code>
<qualifiedValue>
<range>
<!-- todo correct this -->
<low>
<value value="20"/>
<unit value="mg/mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg/mL"/>
</low>
<!-- todo correct this -->
<high>
<value value="21"/>
<unit value="mg/mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg/mL"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:fc07b5d5-9fe1-92c2-2d06-47cb5b295e72"/>
<resource>
<ObservationDefinition>
<!-- AppearanceProduct -->
<id value="fc07b5d5-9fe1-92c2-2d06-47cb5b295e72"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="fc07b5d5-9fe1-92c2-2d06-47cb5b295e72"> </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 "fc07b5d5-9fe1-92c2-2d06-47cb5b295e72" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-47cb5b295e72</code></p><p><b>title</b>: Appearance (Product Container, visual)</p><p><b>status</b>: active</p><p><b>code</b>: Appearance (Product Container, visual) <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>#Appearance (Product Container, visual))</span></p><p><b>method</b>: Visual inspection <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</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/fc07b5d5-9fe1-92c2-2d06-47cb5b295e72 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-47cb5b295e72"/>
<title value="Appearance (Product Container, visual)"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Appearance (Product Container, visual)"/>
<display value="Appearance (Product Container, visual)"/>
</coding>
<text value="Appearance (Product Container, visual)"/>
</code>
<method>
<text value="Visual inspection"/>
</method>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString
value="1) Clear glass vial sealed with a gray rubber stopper and a flip off overseal 2) No visible damage or breach of vial container or closure"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:fc07b5d5-9fe1-92c3-2d16-47cb5b295e72"/>
<resource>
<ObservationDefinition>
<!-- AppearanceLyophilized -->
<id value="fc07b5d5-9fe1-92c3-2d16-47cb5b295e72"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="fc07b5d5-9fe1-92c3-2d16-47cb5b295e72"> </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 "fc07b5d5-9fe1-92c3-2d16-47cb5b295e72" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c3-2d16-47cb5b295e72</code></p><p><b>title</b>: Appearance (Lyophilized, Visual)</p><p><b>status</b>: active</p><p><b>code</b>: Appearance (Lyophilized, Visual) <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>#Appearance (Lyophilized, Visual))</span></p><p><b>method</b>: Visual inspection <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</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/fc07b5d5-9fe1-92c3-2d16-47cb5b295e72 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c3-2d16-47cb5b295e72"/>
<title value="Appearance (Lyophilized, Visual)"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Appearance (Lyophilized, Visual)"/>
<display value="Appearance (Lyophilized, Visual)"/>
</coding>
<text value="Appearance (Lyophilized, Visual)"/>
</code>
<method>
<text value="Visual inspection"/>
</method>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString
value="White to off white cake or powder, essentially free from evidence of contamination with no visible foreign particulates"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:fc07b5d5-9fe1-92c3-2d06-47cb5b295e72"/>
<resource>
<ObservationDefinition>
<!-- AppearanceReconstituted -->
<id value="fc07b5d5-9fe1-92c3-2d06-47cb5b295e72"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="fc07b5d5-9fe1-92c3-2d06-47cb5b295e72"> </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 "fc07b5d5-9fe1-92c3-2d06-47cb5b295e72" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c3-2d06-47cb5b295e72</code></p><p><b>title</b>: Appearance (Reconstituted, Visual)</p><p><b>status</b>: active</p><p><b>code</b>: Appearance (Reconstituted, Visual) <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>#Appearance (Reconstituted, Visual))</span></p><p><b>method</b>: Visual inspection <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</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/fc07b5d5-9fe1-92c3-2d06-47cb5b295e72 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c3-2d06-47cb5b295e72"/>
<title value="Appearance (Reconstituted, Visual)"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Appearance (Reconstituted, Visual)"/>
<display value="Appearance (Reconstituted, Visual)"/>
</coding>
<text value="Appearance (Reconstituted, Visual)"/>
</code>
<method>
<text value="Visual inspection"/>
</method>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString
value="Clear, colorless to slightly yellow solution, essentially free of visible particulates"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:3b0e878e-4bc9-8864-862f-e28b21233e8d"/>
<resource>
<ObservationDefinition>
<!-- Identification -->
<id value="3b0e878e-4bc9-8864-862f-e28b21233e8d"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="3b0e878e-4bc9-8864-862f-e28b21233e8d"> </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 "3b0e878e-4bc9-8864-862f-e28b21233e8d" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d</code></p><p><b>title</b>: Identification</p><p><b>status</b>: active</p><p><b>code</b>: Identification <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>#IDT)</span></p><p><b>method</b>: ID by UHPLC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</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/3b0e878e-4bc9-8864-862f-e28b21233e8d -->
<url
value="http://example-server.com/fhir/ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d"/>
<title value="Identification"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IDT"/>
<display value="Identification"/>
</coding>
<text value="Identification"/>
</code>
<method>
<text value="ID by UHPLC"/>
</method>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString
value="Consistent with the retention time and UV spectrum of the reference standard"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
<resource>
<ObservationDefinition>
<!-- Assay -->
<id value="12e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="12e7e672-40a6-4036-3c1f-b8ba6a7d045e"> </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 "12e7e672-40a6-4036-3c1f-b8ba6a7d045e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay <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>#ASSAY)</span></p><p><b>method</b>: Assay by UHPLC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</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/12e7e672-40a6-4036-3c1f-b8ba6a7d045e -->
<url
value="http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
<title value="Assay"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
<text value="Assay"/>
</code>
<method>
<text value="Assay by UHPLC"/>
</method>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString value="95% to 105% of label claim"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
<resource>
<ObservationDefinition>
<!-- Degradation -->
<id value="8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="8bdea820-4197-7c7d-0990-7be06bf78aaf"> </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 "8bdea820-4197-7c7d-0990-7be06bf78aaf" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf</code></p><p><b>title</b>: Degradation Products</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><p><b>method</b>: Degradation products by UHPLC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</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>: ?-0.2</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>: ?-0.3</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>: ?-0.3</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Individual unspecified degradation products <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 products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-1.4</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/8bdea820-4197-7c7d-0990-7be06bf78aaf -->
<url
value="http://example-server.com/fhir/ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
<title value="Degradation Products"/>
<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>
<method>
<text value="Degradation products by UHPLC"/>
</method>
<qualifiedValue>
<appliesTo>
<!-- could be a code -->
<text value="Impurity 1"/>
</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="Impurity 2"/>
</appliesTo>
<range>
<high>
<value value="0.3"/>
<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="0.3"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Individual unspecified degradation products"/>
</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 products"/>
</appliesTo>
<range>
<high>
<value value="1.4"/>
<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:31e29d22-5fcb-546e-24fd-52a4a4004467"/>
<resource>
<ObservationDefinition>
<!-- Water -->
<id value="31e29d22-5fcb-546e-24fd-52a4a4004467"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="31e29d22-5fcb-546e-24fd-52a4a4004467"> </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 "31e29d22-5fcb-546e-24fd-52a4a4004467" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467</code></p><p><b>title</b>: Water Content</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><p><b>method</b>: USP <921> <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</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>?-1.0</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467"/>
<title value="Water Content"/>
<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>
<method>
<text value="USP <921>"/>
</method>
<qualifiedValue>
<range>
<high>
<value value="1.0"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:32e29d22-5fcb-546e-24fd-52a4a4004467"/>
<resource>
<ObservationDefinition>
<!-- LyophilizationWater -->
<id value="32e29d22-5fcb-546e-24fd-52a4a4004467"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="32e29d22-5fcb-546e-24fd-52a4a4004467"> </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 "32e29d22-5fcb-546e-24fd-52a4a4004467" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/32e29d22-5fcb-546e-24fd-52a4a4004467</code></p><p><b>title</b>: Water Content</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><p><b>method</b>: USP <921> <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</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>?-1.2</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/32e29d22-5fcb-546e-24fd-52a4a4004467 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/32e29d22-5fcb-546e-24fd-52a4a4004467"/>
<title value="Water Content"/>
<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>
<method>
<text value="USP <921>"/>
</method>
<qualifiedValue>
<range>
<high>
<value value="1.2"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:32e29d22-6fcb-546e-24fd-52a4a4004467"/>
<resource>
<ObservationDefinition>
<!-- LyophilizationWaterHomogeneity -->
<id value="32e29d22-6fcb-546e-24fd-52a4a4004467"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="32e29d22-6fcb-546e-24fd-52a4a4004467"> </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 "32e29d22-6fcb-546e-24fd-52a4a4004467" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467</code></p><p><b>title</b>: Water Content</p><p><b>status</b>: active</p><p><b>code</b>: Moisture (%) <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>#WWWH "Water Content Homogeneity")</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td/><td>-1.5-1.5 % w/w</td></tr></table><blockquote><p><b>component</b></p><p><b>code</b>: Do statistically significant effects <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>#SSE "Statistically significant effects")</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Lower one-sided 95% confidence limit of Max Difference <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>#LCL)</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Upper one-sided 95% confidence limit of Max Difference <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>#UCL)</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Was Homogeneity demonstrated? <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>#Homogeneity "Homogeneity demonstrated")</span></p></blockquote></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467"/>
<title value="Water Content"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="WWWH"/>
<display value="Water Content Homogeneity"/>
</coding>
<text value="Moisture (%)"/>
</code>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq">
<valueString value="± 1.4 % (w/w)"/>
</extension>
<range>
<low>
<value value="-1.5"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</low>
<high>
<value value="1.5"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="SSE"/>
<display value="Statistically significant effects"/>
</coding>
<text value="Do statistically significant effects"/>
</code>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="LCL"/>
<display
value="Lower one-sided 95% confidence limit of Max Difference"/>
</coding>
<text
value="Lower one-sided 95% confidence limit of Max Difference"/>
</code>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="UCL"/>
<display
value="Upper one-sided 95% confidence limit of Max Difference"/>
</coding>
<text
value="Upper one-sided 95% confidence limit of Max Difference"/>
</code>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Homogeneity"/>
<display value="Homogeneity demonstrated"/>
</coding>
<text value="Was Homogeneity demonstrated?"/>
</code>
</component>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:32e29d32-6fcb-546e-24fd-52a4a4004467"/>
<resource>
<ObservationDefinition>
<!-- LyophilizationAssayHomogeneity -->
<id value="32e29d32-6fcb-546e-24fd-52a4a4004467"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="32e29d32-6fcb-546e-24fd-52a4a4004467"> </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 "32e29d32-6fcb-546e-24fd-52a4a4004467" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay by HPLC (% Main Peak) <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>#ASSH "Assay Content Homogeneity")</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td/><td>-2.3-2.3 %</td></tr></table><blockquote><p><b>component</b></p><p><b>code</b>: Do statistically significant effects <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>#SSE "Statistically significant effects")</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Lower one-sided 95% confidence limit of Max Difference <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>#LCL)</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Upper one-sided 95% confidence limit of Max Difference <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>#UCL)</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Was Homogeneity demonstrated? <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>#Homogeneity "Homogeneity demonstrated")</span></p></blockquote></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467"/>
<title value="Assay"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSH"/>
<display value="Assay Content Homogeneity"/>
</coding>
<text value="Assay by HPLC (% Main Peak)"/>
</code>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq">
<valueString value="± 2.3%"/>
</extension>
<range>
<low>
<value value="-2.3"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</low>
<high>
<value value="2.3"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="SSE"/>
<display value="Statistically significant effects"/>
</coding>
<text value="Do statistically significant effects"/>
</code>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="LCL"/>
<display
value="Lower one-sided 95% confidence limit of Max Difference"/>
</coding>
<text
value="Lower one-sided 95% confidence limit of Max Difference"/>
</code>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="UCL"/>
<display
value="Upper one-sided 95% confidence limit of Max Difference"/>
</coding>
<text
value="Upper one-sided 95% confidence limit of Max Difference"/>
</code>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Homogeneity"/>
<display value="Homogeneity demonstrated"/>
</coding>
<text value="Was Homogeneity demonstrated?"/>
</code>
</component>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:ef17cff1-6586-a5a4-9168-2602140548d7"/>
<resource>
<ObservationDefinition>
<!-- UniformityUSP -->
<id value="ef17cff1-6586-a5a4-9168-2602140548d7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="ef17cff1-6586-a5a4-9168-2602140548d7"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "ef17cff1-6586-a5a4-9168-2602140548d7" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d7</code></p><p><b>title</b>: Uniformity of Dosage Units, Weight Variation - Meets USP / Ph. Eur. requirements (% label claim)</p><p><b>status</b>: active</p><p><b>code</b>: Uniformity of Dosage Units, Weight Variation <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 of Dosage Units, Weight Variation)</span></p><p><b>method</b>: Weight variation <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</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>97-? %</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d7 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d7"/>
<title
value="Uniformity of Dosage Units, Weight Variation - Meets USP / Ph. Eur. requirements (% label claim)"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Uniformity of Dosage Units, Weight Variation"/>
<display value="Uniformity of Dosage Units, Weight Variation"/>
</coding>
<text value="Uniformity of Dosage Units, Weight Variation"/>
</code>
<method>
<text value="Weight variation"/>
</method>
<qualifiedValue>
<range>
<low>
<value value="97"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</low>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:ef17cff1-6586-a5a4-9168-2602140548d8"/>
<resource>
<ObservationDefinition>
<!-- UniformityAcceptance -->
<id value="ef17cff1-6586-a5a4-9168-2602140548d8"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="ef17cff1-6586-a5a4-9168-2602140548d8"> </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 "ef17cff1-6586-a5a4-9168-2602140548d8" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d8</code></p><p><b>title</b>: Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)</p><p><b>status</b>: active</p><p><b>code</b>: Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV) <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 of Dosage Units, Weight Variation - Acceptance Value (AV))</span></p><p><b>method</b>: Weight variation <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</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>?-25</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d8 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/ef17cff1-6586-a5a4-9168-2602140548d8"/>
<title
value="Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code
value="Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)"/>
<display
value="Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)"/>
</coding>
<text
value="Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)"/>
</code>
<method>
<text value="Weight variation"/>
</method>
<qualifiedValue>
<range>
<!-- what are units of acceptance value? -->
<high>
<value value="25"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:fc17b5d6-9fe1-91c2-2d06-47cb5b295e72"/>
<resource>
<ObservationDefinition>
<!-- releasepH -->
<id value="fc17b5d6-9fe1-91c2-2d06-47cb5b295e72"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="fc17b5d6-9fe1-91c2-2d06-47cb5b295e72"> </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 "fc17b5d6-9fe1-91c2-2d06-47cb5b295e72" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d06-47cb5b295e72</code></p><p><b>title</b>: pH (reconstituted)</p><p><b>status</b>: active</p><p><b>code</b>: pH (reconstituted) <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>#pH (reconstituted))</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>6.95-7.05 pH</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d06-47cb5b295e72 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d06-47cb5b295e72"/>
<title value="pH (reconstituted)"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="pH (reconstituted)"/>
<display value="pH (reconstituted)"/>
</coding>
<text value="pH (reconstituted)"/>
</code>
<qualifiedValue>
<range>
<low>
<value value="6.95"/>
<unit value="pH"/>
<system value="http://unitsofmeasure.org"/>
<code value="pH"/>
</low>
<high>
<value value="7.05"/>
<unit value="pH"/>
<system value="http://unitsofmeasure.org"/>
<code value="pH"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<!-- filling steps -->
<entry>
<fullUrl value="urn:uuid:22515a3c-5034-448a-9c19-938ce1958424"/>
<resource>
<ObservationDefinition>
<!-- conclusion -->
<id value="22515a3c-5034-448a-9c19-938ce1958424"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="22515a3c-5034-448a-9c19-938ce1958424"> </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 "22515a3c-5034-448a-9c19-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424</code></p><p><b>title</b>: Conclusion</p><p><b>status</b>: active</p><p><b>code</b>: Conclusion <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>#CONC)</span></p></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424"/>
<title value="Conclusion"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="CONC"/>
<display value="Conclusion"/>
</coding>
<text value="Conclusion"/>
</code>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:64505a3c-5034-448a-9c19-938ce1958424"/>
<resource>
<ObservationDefinition>
<!-- TAMC -->
<id value="64505a3c-5034-448a-9c19-938ce1958424"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="64505a3c-5034-448a-9c19-938ce1958424"> </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 "64505a3c-5034-448a-9c19-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64505a3c-5034-448a-9c19-938ce1958424</code></p><p><b>title</b>: TAMC [a]</p><p><b>status</b>: active</p><p><b>code</b>: TAMC <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>#TAMC)</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>?-10</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/64505a3c-5034-448a-9c19-938ce1958424 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/64505a3c-5034-448a-9c19-938ce1958424"/>
<title value="TAMC [a]"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="TAMC"/>
<display value="TAMC"/>
</coding>
<text value="TAMC"/>
</code>
<qualifiedValue>
<range>
<!-- todo UCUM -->
<high>
<value value="10"/>
<unit value="CFU/100ml"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:64515a3c-5034-448a-9c19-938ce1958424"/>
<resource>
<ObservationDefinition>
<!-- TYMC -->
<id value="64515a3c-5034-448a-9c19-938ce1958424"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="64515a3c-5034-448a-9c19-938ce1958424"> </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 "64515a3c-5034-448a-9c19-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424</code></p><p><b>title</b>: TYMC [a]</p><p><b>status</b>: active</p><p><b>code</b>: TAMC <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>#TAMC)</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>?-10</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424"/>
<title value="TYMC [a]"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="TAMC"/>
<display value="TAMC"/>
</coding>
<text value="TAMC"/>
</code>
<qualifiedValue>
<range>
<!-- todo UCUM -->
<high>
<value value="10"/>
<unit value="CFU/100ml"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:64515a3c-5134-448a-9c19-938ce1958424"/>
<resource>
<ObservationDefinition>
<!-- FillWeightAverage -->
<id value="64515a3c-5134-448a-9c19-938ce1958424"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="64515a3c-5134-448a-9c19-938ce1958424"> </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 "64515a3c-5134-448a-9c19-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-938ce1958424</code></p><p><b>title</b>: Fill Weight Average</p><p><b>status</b>: active</p><p><b>code</b>: Fill Weight Average <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>#Fill Weight Average)</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/64515a3c-5134-448a-9c19-938ce1958424 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-938ce1958424"/>
<title value="Fill Weight Average"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Fill Weight Average"/>
<display value="Fill Weight Average"/>
</coding>
</code>
<qualifiedValue>
<!-- todo probably want to just not have this, detect that, and show as N/A -->
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString value="N/A"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:64525a3c-5134-448a-9c19-938ce1958424"/>
<resource>
<ObservationDefinition>
<!-- FillWeightTarget -->
<id value="64525a3c-5134-448a-9c19-938ce1958424"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="64525a3c-5134-448a-9c19-938ce1958424"> </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 "64525a3c-5134-448a-9c19-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64525a3c-5134-448a-9c19-938ce1958424</code></p><p><b>title</b>: Fill Weight Target</p><p><b>status</b>: active</p><p><b>code</b>: Fill Weight Target (g) <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>#Fill Weight Target (g))</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/64525a3c-5134-448a-9c19-938ce1958424 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/64525a3c-5134-448a-9c19-938ce1958424"/>
<title value="Fill Weight Target"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Fill Weight Target (g)"/>
<display value="Fill Weight Target (g)"/>
</coding>
</code>
<qualifiedValue>
<!-- todo probably want to just not have this, detect that, and show as N/A -->
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString value="N/A"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:64515a3c-5134-448a-9c29-938ce1958424"/>
<resource>
<ObservationDefinition>
<!-- FillWeightAverageFromTarget -->
<id value="64515a3c-5134-448a-9c29-938ce1958424"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="64515a3c-5134-448a-9c29-938ce1958424"> </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 "64515a3c-5134-448a-9c29-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c29-938ce1958424</code></p><p><b>title</b>: Actual Avg. Weight from Target</p><p><b>status</b>: active</p><p><b>code</b>: Actual Avg. Weight from Target <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>#Actual Avg. Weight from Target)</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td/><td>2-2 %</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c29-938ce1958424 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c29-938ce1958424"/>
<title value="Actual Avg. Weight from Target"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Actual Avg. Weight from Target"/>
<display value="Actual Avg. Weight from Target"/>
</coding>
</code>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq">
<valueString value="± 2% target (%)"/>
</extension>
<range>
<low>
<value value="2"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</low>
<high>
<value value="2"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:64515a3c-5234-448a-9c29-938ce1958424"/>
<resource>
<ObservationDefinition>
<!-- HoldTimeFiltrationToFilling -->
<id value="64515a3c-5234-448a-9c29-938ce1958424"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="64515a3c-5234-448a-9c29-938ce1958424"> </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 "64515a3c-5234-448a-9c29-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64515a3c-5234-448a-9c29-938ce1958424</code></p><p><b>title</b>: Hold Time (filtration To filling)</p><p><b>status</b>: active</p><p><b>code</b>: Hold Time (filtration To filling) <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>#Hold Time (filtration To filling))</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>?-2.5</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/64515a3c-5234-448a-9c29-938ce1958424 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/64515a3c-5234-448a-9c29-938ce1958424"/>
<title value="Hold Time (filtration To filling)"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Hold Time (filtration To filling)"/>
<display value="Hold Time (filtration To filling)"/>
</coding>
</code>
<qualifiedValue>
<range>
<high>
<value value="2.5"/>
<unit value="hours"/>
<system value="http://unitsofmeasure.org"/>
<code value="h"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:64515a3c-5334-448a-9c29-938ce1958424"/>
<resource>
<ObservationDefinition>
<!-- HoldTimeFilling -->
<id value="64515a3c-5334-448a-9c29-938ce1958424"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="64515a3c-5334-448a-9c29-938ce1958424"> </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 "64515a3c-5334-448a-9c29-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64515a3c-5334-448a-9c29-938ce1958424</code></p><p><b>title</b>: Hold Time (start filling to end filling)</p><p><b>status</b>: active</p><p><b>code</b>: Hold Time (start filling to end filling) <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>#Hold Time (start filling to end filling))</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>?-1.25</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/64515a3c-5334-448a-9c29-938ce1958424 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/64515a3c-5334-448a-9c29-938ce1958424"/>
<title value="Hold Time (start filling to end filling)"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Hold Time (start filling to end filling)"/>
<display value="Hold Time (start filling to end filling)"/>
</coding>
</code>
<qualifiedValue>
<range>
<high>
<value value="1.25"/>
<unit value="hours"/>
<system value="http://unitsofmeasure.org"/>
<code value="h"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:64535a3c-5334-448a-9c29-938ce1958424"/>
<resource>
<ObservationDefinition>
<!-- FilterIntegrity -->
<id value="64535a3c-5334-448a-9c29-938ce1958424"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="64535a3c-5334-448a-9c29-938ce1958424"> </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 "64535a3c-5334-448a-9c29-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce1958424</code></p><p><b>title</b>: Filter Integrity Test</p><p><b>status</b>: active</p><p><b>code</b>: Filter Integrity Test <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>#Filter Integrity Test)</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>3.5-? psi</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce1958424 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce1958424"/>
<title value="Filter Integrity Test"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Filter Integrity Test"/>
<display value="Filter Integrity Test"/>
</coding>
</code>
<qualifiedValue>
<range>
<!-- out of scope of ucum apparently -->
<low>
<value value="3.5"/>
<unit value="psi"/>
<system value="http://unitsofmeasure.org"/>
<code value="[psi]"/>
</low>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<!-- Lyophilization step -->
<entry>
<fullUrl value="urn:uuid:22525a3c-5034-448a-9c19-938ce1958424"/>
<resource>
<ObservationDefinition>
<!-- LyophilizationConclusion -->
<id value="22525a3c-5034-448a-9c19-938ce1958424"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="22525a3c-5034-448a-9c19-938ce1958424"> </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 "22525a3c-5034-448a-9c19-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424</code></p><p><b>title</b>: Conclusion</p><p><b>status</b>: active</p><p><b>code</b>: Conclusion <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>#CONC)</span></p></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424"/>
<title value="Conclusion"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="CONC"/>
<display value="Conclusion"/>
</coding>
<text value="Conclusion"/>
</code>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:64535a3c-5334-448a-9c29-938ce2958424"/>
<!-- qualifiedValue>
</qualifiedValue -->
<resource>
<ObservationDefinition>
<!-- LyophilizerNumber -->
<id value="64535a3c-5334-448a-9c29-938ce2958424"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="64535a3c-5334-448a-9c29-938ce2958424"> </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 "64535a3c-5334-448a-9c29-938ce2958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424</code></p><p><b>title</b>: Lyophilizer Number</p><p><b>status</b>: active</p><p><b>code</b>: Lyophilizer Number <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>#Lyophilizer Number)</span></p></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424"/>
<title value="Lyophilizer Number"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Lyophilizer Number"/>
<display value="Lyophilizer Number"/>
</coding>
</code>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:22e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
<resource>
<ObservationDefinition>
<!-- LyophilizationAssay -->
<id value="22e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="22e7e672-40a6-4036-3c1f-b8ba6a7d045e"> </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 "22e7e672-40a6-4036-3c1f-b8ba6a7d045e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay <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>#ASSAY)</span></p><p><b>method</b>: Assay by UHPLC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td/><td>95-105 %</td></tr></table><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>Number of Locations <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>#LOC)</span></td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e -->
<url
value="http://example-server.com/fhir/ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
<title value="Assay"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
<text value="Assay"/>
</code>
<method>
<text value="Assay by UHPLC"/>
</method>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-display-pq">
<valueString value="95% to 105% of label claim"/>
</extension>
<range>
<low>
<value value="95"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</low>
<high>
<value value="105"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
<component>
<!-- are expected to have a component that says number of locations -->
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="LOC"/>
<display value="Number of Locations"/>
</coding>
</code>
</component>
</ObservationDefinition>
</resource>
</entry>
<!-- Section 8 - Batch or Lot Information (batch 1 of 3) -->
<entry>
<fullUrl value="urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
<resource>
<Medication>
<!-- medication-batch-information-drug-pq-ex1 -->
<id value="339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
<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="339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"> </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 "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51" </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>
<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="closureSystemDescription">
<valueString value="100 cc HDPE Bottle 2 g desiccant"/>
</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-designation-pq">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-batch-designation-local-pq"/>
<code value="maximum"/>
<display value="Maximum"/>
</coding>
<text value="Maximum"/>
</valueCodeableConcept>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-number-of-vials-pq">
<valuePositiveInt value="3"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-substance-batch-pq">
<valueReference>
<!-- Substance/substance-drug-pq-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/organization-drug-pq-ex1 -->
<reference
value="Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c"/>
</valueReference>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq">
<valueQuantity>
<value value="4.81"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-unfiltered-pq">
<valueQuantity>
<value value="4.91"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-target-fill-weight-pq">
<valueQuantity>
<value value="30"/>
<unit value="g"/>
</valueQuantity>
</extension>
<lotNumber value="33445"/>
</batch>
</Medication>
</resource>
</entry>
<!-- Section 8 - Batch or Lot Information (another batch 2 of 3) -->
<entry>
<fullUrl value="urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
<resource>
<Medication>
<!-- medication-actual-batch-2 -->
<id value="a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Medication</b><a name="a9dfda53-734b-045f-7ae4-94a6281d53bc"> </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 "a9dfda53-734b-045f-7ae4-94a6281d53bc" </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>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C185328"/>
<display value="Stability Study"/>
</coding>
<text value="PPQ / Stability"/>
</valueCodeableConcept>
</extension>
<extension url="assignedManufacturer">
<valueReference>
<!-- Organization/manufacturer -->
<reference
value="Organization/0102bca4-46c1-a6bf-1025-cd403fee710a"/>
</valueReference>
</extension>
<extension url="container">
<extension url="closureSystemDescription">
<valueString value="100 cc HDPE Bottle 2 g desiccant"/>
</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-designation-pq">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-batch-designation-local-pq"/>
<code value="maximum"/>
<display value="Maximum"/>
</coding>
<text value="Maximum"/>
</valueCodeableConcept>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-number-of-vials-pq">
<valuePositiveInt value="4"/>
</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/378fbe5f-5926-3a5c-4c64-5428df877b07"/>
</valueReference>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq">
<valueQuantity>
<value value="4.82"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-unfiltered-pq">
<valueQuantity>
<value value="4.92"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-target-fill-weight-pq">
<valueQuantity>
<value value="30"/>
<unit value="g"/>
</valueQuantity>
</extension>
<lotNumber value="33446"/>
</batch>
</Medication>
</resource>
</entry>
<!-- Section 8 - Batch or Lot Information (another batch 3 of 3) -->
<entry>
<fullUrl value="urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
<resource>
<Medication>
<!-- medication-actual-batch-3 -->
<id value="c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Medication</b><a name="c6f5fadd-62e6-3a01-93d9-b3b182f67d06"> </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 "c6f5fadd-62e6-3a01-93d9-b3b182f67d06" </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>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C185328"/>
<display value="Stability Study"/>
</coding>
<text value="PPQ / Stability"/>
</valueCodeableConcept>
</extension>
<extension url="assignedManufacturer">
<valueReference>
<!-- Organization/manufacturer -->
<reference
value="Organization/0102bca4-46c1-a6bf-1025-cd403fee710a"/>
</valueReference>
</extension>
<extension url="container">
<extension url="closureSystemDescription">
<valueString value="100 cc HDPE Bottle 2 g desiccant"/>
</extension>
</extension>
</extension>
<!-- local exensions -->
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq">
<valueDateTime value="2019-09-08"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-designation-pq">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-batch-designation-local-pq"/>
<code value="maximum"/>
<display value="Maximum"/>
</coding>
<text value="Maximum"/>
</valueCodeableConcept>
</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-batch-number-of-vials-pq">
<valuePositiveInt value="3"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-substance-batch-pq">
<valueReference>
<!-- 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-site-pq">
<valueReference>
<!-- Organization/packaging -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b07"/>
</valueReference>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq">
<valueQuantity>
<value value="4.83"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-unfiltered-pq">
<valueQuantity>
<value value="4.93"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-target-fill-weight-pq">
<valueQuantity>
<value value="30"/>
<unit value="g"/>
</valueQuantity>
</extension>
<lotNumber value="33447"/>
</batch>
</Medication>
</resource>
</entry>
<!-- Section 4.1 - Manufacturer -->
<entry>
<fullUrl value="urn:uuid:0102bca4-46c1-a6bf-1025-cd403fee710a"/>
<resource>
<Organization>
<!-- manufacturer -->
<id value="0102bca4-46c1-a6bf-1025-cd403fee710a"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="0102bca4-46c1-a6bf-1025-cd403fee710a"> </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 "0102bca4-46c1-a6bf-1025-cd403fee710a" </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>
<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:378fbe5f-5926-3a5c-4c64-5428df877b07"/>
<resource>
<Organization>
<!-- packaging -->
<id value="378fbe5f-5926-3a5c-4c64-5428df877b07"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="378fbe5f-5926-3a5c-4c64-5428df877b07"> </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 "378fbe5f-5926-3a5c-4c64-5428df877b07" </p></div><p><b>name</b>: MySite</p></div>
</text>
<name value="MySite"/>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08"/>
<resource>
<Organization>
<!-- testing lab -->
<!-- 378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<id value="378fbe5f-5926-3a5c-4c64-5428df877b08"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="378fbe5f-5926-3a5c-4c64-5428df877b08"> </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 "378fbe5f-5926-3a5c-4c64-5428df877b08" </p></div><p><b>name</b>: Testing Lab</p></div>
</text>
<name value="Testing Lab"/>
</Organization>
</resource>
</entry>
<!-- Diagnostic report doesn't carry much extra value but does collect all the observations -->
<entry>
<fullUrl value="urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd"/>
<resource>
<DiagnosticReport>
<!-- ideally this wants a subject, but it can only be a Medication (batch) and we have multiple.
however the observations themselves do have subjects -->
<id value="processValidationReport"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: DiagnosticReport</b><a name="processValidationReport"> </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 "processValidationReport" </p></div><p><b>Triggered by</b>: <a href="#PlanDefinition_2038e4c7-22b8-4c56-2d28-6c077648763f">See above (PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Process Validation Report <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-reportType-local-pq.html">CodeSystem - Report Type</a>#Process Validation Report)</span></p><p><b>effective</b>: 2020-12</p><p><b>result</b>: </p><ul><li><a href="#Observation_9c56948a-2a39-6609-1c01-4d197ea57a33">See above (Observation/9c56948a-2a39-6609-1c01-4d197ea57a33)</a></li><li><a href="#Observation_9c56948a-3a39-6609-1c01-4d197ea57a33">See above (Observation/9c56948a-3a39-6609-1c01-4d197ea57a33)</a></li><li><a href="#Observation_9c56948a-4a39-6609-1c01-4d197ea57a33">See above (Observation/9c56948a-4a39-6609-1c01-4d197ea57a33)</a></li><li><a href="#Observation_9c56948a-3a49-6609-1c01-4d197ea57a33">See above (Observation/9c56948a-3a49-6609-1c01-4d197ea57a33)</a></li><li><a href="#Observation_9c56958a-4a39-6609-1c01-4d197ea57a33">See above (Observation/9c56958a-4a39-6609-1c01-4d197ea57a33)</a></li><li><a href="#Observation_9c56948a-5a39-6609-1c01-4d197ea57a33">See above (Observation/9c56948a-5a39-6609-1c01-4d197ea57a33)</a></li><li><a href="#Observation_9c56948a-2a39-6609-1c01-4d297ea57a33">See above (Observation/9c56948a-2a39-6609-1c01-4d297ea57a33)</a></li><li><a href="#Observation_9c56948a-3a39-6619-1c01-4d197ea57a33">See above (Observation/9c56948a-3a39-6619-1c01-4d197ea57a33)</a></li><li><a href="#Observation_9c56948a-4a39-6619-1c01-4d197ea57a33">See above (Observation/9c56948a-4a39-6619-1c01-4d197ea57a33)</a></li><li><a href="#Observation_9c56948a-3a49-6619-1c01-4d197ea57a33">See above (Observation/9c56948a-3a49-6619-1c01-4d197ea57a33)</a></li><li><a href="#Observation_9c56958a-4a39-6619-1c01-4d197ea57a33">See above (Observation/9c56958a-4a39-6619-1c01-4d197ea57a33)</a></li><li><a href="#Observation_9c56948a-5a39-6709-1c01-4d197ea57a33">See above (Observation/9c56948a-5a39-6709-1c01-4d197ea57a33)</a></li><li><a href="#Observation_f0a04328-905c-4ec5-372e-4d6cfef18629">See above (Observation/f0a04328-905c-4ec5-372e-4d6cfef18629)</a></li><li><a href="#Observation_5e5a5e67-7fc6-0064-1be9-5d9d14d887e5">See above (Observation/5e5a5e67-7fc6-0064-1be9-5d9d14d887e5)</a></li><li><a href="#Observation_cfde6776-673c-72e2-68c4-07b77cd85b74">See above (Observation/cfde6776-673c-72e2-68c4-07b77cd85b74)</a></li><li><a href="#Observation_9c56948a-1a39-6609-1c01-4d197ea57a33">See above (Observation/9c56948a-1a39-6609-1c01-4d197ea57a33)</a></li><li><a href="#Observation_1e20aed7-7626-1664-8d96-235f860d9a2c">See above (Observation/1e20aed7-7626-1664-8d96-235f860d9a2c)</a></li><li><a href="#Observation_ec6d7e30-4d70-491b-0669-a613eedd3c60">See above (Observation/ec6d7e30-4d70-491b-0669-a613eedd3c60)</a></li><li><a href="#Observation_ab7997fa-7b46-1175-3f01-6f6997f7878a">See above (Observation/ab7997fa-7b46-1175-3f01-6f6997f7878a)</a></li><li><a href="#Observation_4052f28b-64a2-392d-35e4-ec8e912434d2">See above (Observation/4052f28b-64a2-392d-35e4-ec8e912434d2)</a></li><li><a href="#Observation_34ebc51d-8105-0589-3c8d-e7aa6bd0a06c">See above (Observation/34ebc51d-8105-0589-3c8d-e7aa6bd0a06c)</a></li><li><a href="#Observation_2940bf11-05bf-6ce2-3c64-457d0d1f9913">See above (Observation/2940bf11-05bf-6ce2-3c64-457d0d1f9913)</a></li><li><a href="#Observation_332b1e76-6f70-2b4e-5d0c-f22a0e042d3e">See above (Observation/332b1e76-6f70-2b4e-5d0c-f22a0e042d3e)</a></li><li><a href="#Observation_f0a13a3b-2e8b-594f-6874-6050511e4c57">See above (Observation/f0a13a3b-2e8b-594f-6874-6050511e4c57)</a></li><li><a href="#Observation_7fe7ccd7-6449-0186-2282-3eeb4cf6a795">See above (Observation/7fe7ccd7-6449-0186-2282-3eeb4cf6a795)</a></li><li><a href="#Observation_be016630-8754-7414-9014-21e020ad66c6">See above (Observation/be016630-8754-7414-9014-21e020ad66c6)</a></li><li><a href="#Observation_92568f68-78f3-908c-6935-ff5f3d574dd6">See above (Observation/92568f68-78f3-908c-6935-ff5f3d574dd6)</a></li><li><a href="#Observation_a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12">See above (Observation/a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12)</a></li><li><a href="#Observation_d8533dcb-03f8-5997-6ccf-4f9b6f7a5745">See above (Observation/d8533dcb-03f8-5997-6ccf-4f9b6f7a5745)</a></li><li><a href="#Observation_7cec19a2-34a7-6b80-3d60-083b2cc64fcb">See above (Observation/7cec19a2-34a7-6b80-3d60-083b2cc64fcb)</a></li><li><a href="#Observation_27aa47fd-7964-4f96-6495-b2bec7f160e7">See above (Observation/27aa47fd-7964-4f96-6495-b2bec7f160e7)</a></li><li><a href="#Observation_6a78bcde-4781-226c-946e-a4b6915c1899">See above (Observation/6a78bcde-4781-226c-946e-a4b6915c1899)</a></li><li><a href="#Observation_f9f11088-7527-947c-3d3f-e71b32e13c78">See above (Observation/f9f11088-7527-947c-3d3f-e71b32e13c78)</a></li><li><a href="#Observation_66c2f585-678e-78b8-2235-1a3b37bd6e46">See above (Observation/66c2f585-678e-78b8-2235-1a3b37bd6e46)</a></li><li><a href="#Observation_f8232d25-023d-679f-9c58-a6dc234b7a28">See above (Observation/f8232d25-023d-679f-9c58-a6dc234b7a28)</a></li><li><a href="#Observation_368b82be-75dd-1d97-3dbc-a7eed9869daa">See above (Observation/368b82be-75dd-1d97-3dbc-a7eed9869daa)</a></li><li><a href="#Observation_44aa47fd-8964-4f96-6495-b2bec7f160e7">See above (Observation/44aa47fd-8964-4f96-6495-b2bec7f160e7)</a></li><li><a href="#Observation_45aa47fd-8964-4f96-6495-b2bec7f160e7">See above (Observation/45aa47fd-8964-4f96-6495-b2bec7f160e7)</a></li><li><a href="#Observation_45ab47fd-8964-4f96-6495-b2bec7f160e7">See above (Observation/45ab47fd-8964-4f96-6495-b2bec7f160e7)</a></li><li><a href="#Observation_37aa47fd-8964-4f96-6495-b2bec7f160e7">See above (Observation/37aa47fd-8964-4f96-6495-b2bec7f160e7)</a></li><li><a href="#Observation_38aa47fd-8964-4f96-6495-b2bec7f160e7">See above (Observation/38aa47fd-8964-4f96-6495-b2bec7f160e7)</a></li><li><a href="#Observation_38aa48fd-8964-4f96-6495-b2bec7f160e7">See above (Observation/38aa48fd-8964-4f96-6495-b2bec7f160e7)</a></li><li><a href="#Observation_37aa47fd-7964-4f96-6495-b2bec7f160e7">See above (Observation/37aa47fd-7964-4f96-6495-b2bec7f160e7)</a></li><li><a href="#Observation_47aa47fd-7964-4f96-6495-b2bec7f160e7">See above (Observation/47aa47fd-7964-4f96-6495-b2bec7f160e7)</a></li><li><a href="#Observation_47aa47fd-7964-4f96-6495-b2bec7f160e8">See above (Observation/47aa47fd-7964-4f96-6495-b2bec7f160e8)</a></li><li><a href="#Observation_47aa47fd-8964-4f96-6495-b2bec7f160e7">See above (Observation/47aa47fd-8964-4f96-6495-b2bec7f160e7)</a></li><li><a href="#Observation_47aa47fd-8964-5f96-6495-b2bec7f160e7">See above (Observation/47aa47fd-8964-5f96-6495-b2bec7f160e7)</a></li></ul><p><b>conclusion</b>: The samples have been assessed and the conclusion is...</p></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>
<!-- PlanDefinition/validationProtocol -->
<reference
value="PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f"/>
</valueReference>
</extension>
<status value="final"/>
<code>
<coding>
<system
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<code value="Process Validation Report"/>
<display value="Process Validation Report"/>
</coding>
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<effectiveDateTime value="2020-12"/>
<result>
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<reference
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value="Observation/9c56948a-3a49-6609-1c01-4d197ea57a33"/>
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<reference
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<result>
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value="Observation/7fe7ccd7-6449-0186-2282-3eeb4cf6a795"/>
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value="Observation/be016630-8754-7414-9014-21e020ad66c6"/>
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<reference
value="Observation/92568f68-78f3-908c-6935-ff5f3d574dd6"/>
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value="Observation/a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12"/>
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<result>
<!-- Observation/observationDegradation-imp-unspecified-2 -->
<reference
value="Observation/d8533dcb-03f8-5997-6ccf-4f9b6f7a5745"/>
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<result>
<!-- Observation/observationDegradation-imp-unspecified-3 -->
<reference
value="Observation/7cec19a2-34a7-6b80-3d60-083b2cc64fcb"/>
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<result>
<!-- Observation/observationDegradation-imp-total -->
<reference
value="Observation/27aa47fd-7964-4f96-6495-b2bec7f160e7"/>
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<result>
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<reference
value="Observation/6a78bcde-4781-226c-946e-a4b6915c1899"/>
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<result>
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<reference
value="Observation/f9f11088-7527-947c-3d3f-e71b32e13c78"/>
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<result>
<!-- Observation/observationWater -->
<reference
value="Observation/66c2f585-678e-78b8-2235-1a3b37bd6e46"/>
</result>
<result>
<!-- Observation/observationWater2 -->
<reference
value="Observation/f8232d25-023d-679f-9c58-a6dc234b7a28"/>
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<!-- Observation/observationWater3 -->
<reference
value="Observation/368b82be-75dd-1d97-3dbc-a7eed9869daa"/>
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<!-- Observation/fillingTAMC1 -->
<reference
value="Observation/44aa47fd-8964-4f96-6495-b2bec7f160e7"/>
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<result>
<!-- Observation/fillingConclusion-nosubject -->
<reference
value="Observation/45aa47fd-8964-4f96-6495-b2bec7f160e7"/>
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<result>
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<reference
value="Observation/45ab47fd-8964-4f96-6495-b2bec7f160e7"/>
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<result>
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value="Observation/37aa47fd-8964-4f96-6495-b2bec7f160e7"/>
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<result>
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<reference
value="Observation/38aa47fd-8964-4f96-6495-b2bec7f160e7"/>
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<result>
<!-- Observation/lyophilizerNumber3 -->
<reference
value="Observation/38aa48fd-8964-4f96-6495-b2bec7f160e7"/>
</result>
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<reference
value="Observation/37aa47fd-7964-4f96-6495-b2bec7f160e7"/>
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<result>
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<reference
value="Observation/47aa47fd-7964-4f96-6495-b2bec7f160e7"/>
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<reference
value="Observation/47aa47fd-7964-4f96-6495-b2bec7f160e8"/>
</result>
<result>
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<reference
value="Observation/47aa47fd-8964-4f96-6495-b2bec7f160e7"/>
</result>
<result>
<!-- Observation/lyophilizerAssayHomogeneity1 -->
<reference
value="Observation/47aa47fd-8964-5f96-6495-b2bec7f160e7"/>
</result>
<conclusion
value="The samples have been assessed and the conclusion is..."/>
</DiagnosticReport>
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</entry>
<entry>
<fullUrl value="urn:uuid:f0a04328-905c-4ec5-372e-4d6cfef18629"/>
<resource>
<Observation>
<!-- observationIdentification -->
<id value="f0a04328-905c-4ec5-372e-4d6cfef18629"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="f0a04328-905c-4ec5-372e-4d6cfef18629"> </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 "f0a04328-905c-4ec5-372e-4d6cfef18629" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_3b0e878e-4bc9-8864-862f-e28b21233e8d">See above (ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <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>#IDT)</span></p><p><b>subject</b>: <a href="#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></div>
</text>
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<!-- ObservationDefinition/Identification -->
<reference
value="ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d"/>
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<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IDT"/>
<display value="Identification"/>
</coding>
<text value="Identification"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference value="Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:5e5a5e67-7fc6-0064-1be9-5d9d14d887e5"/>
<resource>
<Observation>
<!-- observationIdentification2 -->
<id value="5e5a5e67-7fc6-0064-1be9-5d9d14d887e5"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="5e5a5e67-7fc6-0064-1be9-5d9d14d887e5"> </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 "5e5a5e67-7fc6-0064-1be9-5d9d14d887e5" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_3b0e878e-4bc9-8864-862f-e28b21233e8d">See above (ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <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>#IDT)</span></p><p><b>subject</b>: <a href="#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Does not comply <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Identification -->
<reference
value="ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IDT"/>
<display value="Identification"/>
</coding>
<text value="Identification"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-2 -->
<reference value="Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueCodeableConcept>
<text value="Does not comply"/>
</valueCodeableConcept>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:cfde6776-673c-72e2-68c4-07b77cd85b74"/>
<resource>
<Observation>
<!-- observationIdentification3 -->
<id value="cfde6776-673c-72e2-68c4-07b77cd85b74"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="cfde6776-673c-72e2-68c4-07b77cd85b74"> </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 "cfde6776-673c-72e2-68c4-07b77cd85b74" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_3b0e878e-4bc9-8864-862f-e28b21233e8d">See above (ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <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>#IDT)</span></p><p><b>subject</b>: <a href="#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Complies <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Identification -->
<reference
value="ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IDT"/>
<display value="Identification"/>
</coding>
<text value="Identification"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-3 -->
<reference value="Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9c56948a-2a39-6609-1c01-4d197ea57a33"/>
<resource>
<Observation>
<!-- compoundingpHPre1 -->
<id value="9c56948a-2a39-6609-1c01-4d197ea57a33"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="9c56948a-2a39-6609-1c01-4d197ea57a33"> </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 "9c56948a-2a39-6609-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_fc17b5d5-9fe1-91c2-2d06-47cb5b295e72">See above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72)</a></p><p><b>status</b>: final</p><p><b>code</b>: pH (adjustment of pre-clarification bulk solution) <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>#pH (adjustment of pre-clarification bulk solution))</span></p><p><b>subject</b>: <a href="#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 6.91 pH<span style="background: LightGoldenRodYellow"> (Details: UCUM code pH = 'pH')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/compoundingpHPre -->
<reference
value="ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="pH (adjustment of pre-clarification bulk solution)"/>
<display
value="pH (adjustment of pre-clarification bulk solution)"/>
</coding>
<text value="pH (adjustment of pre-clarification bulk solution)"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference value="Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="6.91"/>
<unit value="pH"/>
<system value="http://unitsofmeasure.org"/>
<code value="pH"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9c56948a-3a39-6609-1c01-4d197ea57a33"/>
<resource>
<Observation>
<!-- compoundingpHPre2 -->
<id value="9c56948a-3a39-6609-1c01-4d197ea57a33"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="9c56948a-3a39-6609-1c01-4d197ea57a33"> </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 "9c56948a-3a39-6609-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_fc17b5d5-9fe1-91c2-2d06-47cb5b295e72">See above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72)</a></p><p><b>status</b>: final</p><p><b>code</b>: pH (adjustment of pre-clarification bulk solution) <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>#pH (adjustment of pre-clarification bulk solution))</span></p><p><b>subject</b>: <a href="#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 6.92 pH<span style="background: LightGoldenRodYellow"> (Details: UCUM code pH = 'pH')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/compoundingpHPre -->
<reference
value="ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="pH (adjustment of pre-clarification bulk solution)"/>
<display
value="pH (adjustment of pre-clarification bulk solution)"/>
</coding>
<text value="pH (adjustment of pre-clarification bulk solution)"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-2 -->
<reference value="Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="6.92"/>
<unit value="pH"/>
<system value="http://unitsofmeasure.org"/>
<code value="pH"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9c56948a-4a39-6609-1c01-4d197ea57a33"/>
<resource>
<Observation>
<!-- compoundingpHPre3 -->
<id value="9c56948a-4a39-6609-1c01-4d197ea57a33"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="9c56948a-4a39-6609-1c01-4d197ea57a33"> </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 "9c56948a-4a39-6609-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_fc17b5d5-9fe1-91c2-2d06-47cb5b295e72">See above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72)</a></p><p><b>status</b>: final</p><p><b>code</b>: pH (adjustment of pre-clarification bulk solution) <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>#pH (adjustment of pre-clarification bulk solution))</span></p><p><b>subject</b>: <a href="#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 6.93 pH<span style="background: LightGoldenRodYellow"> (Details: UCUM code pH = 'pH')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/compoundingpHPre -->
<reference
value="ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="pH (adjustment of pre-clarification bulk solution)"/>
<display
value="pH (adjustment of pre-clarification bulk solution)"/>
</coding>
<text value="pH (adjustment of pre-clarification bulk solution)"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-3 -->
<reference value="Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="6.93"/>
<unit value="pH"/>
<system value="http://unitsofmeasure.org"/>
<code value="pH"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9c56948a-3a49-6609-1c01-4d197ea57a33"/>
<resource>
<Observation>
<!-- compoundingpHPost1 -->
<id value="9c56948a-3a49-6609-1c01-4d197ea57a33"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="9c56948a-3a49-6609-1c01-4d197ea57a33"> </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 "9c56948a-3a49-6609-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_fc17b5d5-9fe1-91c2-2d06-47cb5b295e73">See above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73)</a></p><p><b>status</b>: final</p><p><b>code</b>: pH (adjustment of pre-clarification bulk solution) <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>#pH (adjustment of pre-clarification bulk solution))</span></p><p><b>subject</b>: <a href="#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 7.01 pH<span style="background: LightGoldenRodYellow"> (Details: UCUM code pH = 'pH')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/compoundingpHPost -->
<reference
value="ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="pH (adjustment of pre-clarification bulk solution)"/>
<display
value="pH (adjustment of pre-clarification bulk solution)"/>
</coding>
<text value="pH (adjustment of pre-clarification bulk solution)"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference value="Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="7.01"/>
<unit value="pH"/>
<system value="http://unitsofmeasure.org"/>
<code value="pH"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9c56958a-4a39-6609-1c01-4d197ea57a33"/>
<resource>
<Observation>
<!-- compoundingpHPost2 -->
<id value="9c56958a-4a39-6609-1c01-4d197ea57a33"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="9c56958a-4a39-6609-1c01-4d197ea57a33"> </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 "9c56958a-4a39-6609-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_fc17b5d5-9fe1-91c2-2d06-47cb5b295e73">See above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73)</a></p><p><b>status</b>: final</p><p><b>code</b>: pH (adjustment of pre-clarification bulk solution) <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>#pH (adjustment of pre-clarification bulk solution))</span></p><p><b>subject</b>: <a href="#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 7.02 pH<span style="background: LightGoldenRodYellow"> (Details: UCUM code pH = 'pH')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/compoundingpHPost -->
<reference
value="ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="pH (adjustment of pre-clarification bulk solution)"/>
<display
value="pH (adjustment of pre-clarification bulk solution)"/>
</coding>
<text value="pH (adjustment of pre-clarification bulk solution)"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-2 -->
<reference value="Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="7.02"/>
<unit value="pH"/>
<system value="http://unitsofmeasure.org"/>
<code value="pH"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9c56948a-5a39-6609-1c01-4d197ea57a33"/>
<resource>
<Observation>
<!-- compoundingpHPost3 -->
<id value="9c56948a-5a39-6609-1c01-4d197ea57a33"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="9c56948a-5a39-6609-1c01-4d197ea57a33"> </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 "9c56948a-5a39-6609-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_fc17b5d5-9fe1-91c2-2d06-47cb5b295e73">See above (ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73)</a></p><p><b>status</b>: final</p><p><b>code</b>: pH (adjustment of pre-clarification bulk solution) <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>#pH (adjustment of pre-clarification bulk solution))</span></p><p><b>subject</b>: <a href="#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 6.93 pH<span style="background: LightGoldenRodYellow"> (Details: UCUM code pH = 'pH')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/compoundingpHPost -->
<reference
value="ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="pH (adjustment of pre-clarification bulk solution)"/>
<display
value="pH (adjustment of pre-clarification bulk solution)"/>
</coding>
<text value="pH (adjustment of pre-clarification bulk solution)"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-3 -->
<reference value="Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="6.93"/>
<unit value="pH"/>
<system value="http://unitsofmeasure.org"/>
<code value="pH"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9c56948a-2a39-6609-1c01-4d297ea57a33"/>
<resource>
<Observation>
<!-- compoundingAssayPre1 -->
<id value="9c56948a-2a39-6609-1c01-4d297ea57a33"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="9c56948a-2a39-6609-1c01-4d297ea57a33"> </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 "9c56948a-2a39-6609-1c01-4d297ea57a33" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_fd17b5d5-9fe1-91c2-2d06-47cb5b295e72">See above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay (pre-clarification filtration) (mg/mL) <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>#Assay (pre-clarification filtration) (mg/mL))</span></p><p><b>subject</b>: <a href="#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 21.1 mg/mL<span style="background: LightGoldenRodYellow"> (Details: UCUM code mg/mL = 'mg/mL')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/compoundingAssayPre -->
<reference
value="ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Assay (pre-clarification filtration) (mg/mL)"/>
<display value="Assay (pre-clarification filtration) (mg/mL)"/>
</coding>
<text value="Assay (pre-clarification filtration) (mg/mL)"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference value="Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="21.1"/>
<unit value="mg/mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg/mL"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9c56948a-3a39-6619-1c01-4d197ea57a33"/>
<resource>
<Observation>
<!-- compoundingAssayPre2 -->
<id value="9c56948a-3a39-6619-1c01-4d197ea57a33"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="9c56948a-3a39-6619-1c01-4d197ea57a33"> </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 "9c56948a-3a39-6619-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_fd17b5d5-9fe1-91c2-2d06-47cb5b295e72">See above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay (pre-clarification filtration) (mg/mL) <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>#Assay (pre-clarification filtration) (mg/mL))</span></p><p><b>subject</b>: <a href="#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 21.2 mg/mL<span style="background: LightGoldenRodYellow"> (Details: UCUM code mg/mL = 'mg/mL')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/compoundingAssayPre -->
<reference
value="ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Assay (pre-clarification filtration) (mg/mL)"/>
<display value="Assay (pre-clarification filtration) (mg/mL)"/>
</coding>
<text value="Assay (pre-clarification filtration) (mg/mL)"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-2 -->
<reference value="Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="21.2"/>
<unit value="mg/mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg/mL"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9c56948a-4a39-6619-1c01-4d197ea57a33"/>
<resource>
<Observation>
<!-- compoundingAssayPre3 -->
<id value="9c56948a-4a39-6619-1c01-4d197ea57a33"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="9c56948a-4a39-6619-1c01-4d197ea57a33"> </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 "9c56948a-4a39-6619-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_fd17b5d5-9fe1-91c2-2d06-47cb5b295e72">See above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay (pre-clarification filtration) (mg/mL) <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>#Assay (pre-clarification filtration) (mg/mL))</span></p><p><b>subject</b>: <a href="#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 21.3 mg/mL<span style="background: LightGoldenRodYellow"> (Details: UCUM code mg/mL = 'mg/mL')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/compoundingAssayPre -->
<reference
value="ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e72"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Assay (pre-clarification filtration) (mg/mL)"/>
<display value="Assay (pre-clarification filtration) (mg/mL)"/>
</coding>
<text value="Assay (pre-clarification filtration) (mg/mL)"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-3 -->
<reference value="Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="21.3"/>
<unit value="mg/mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg/mL"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9c56948a-3a49-6619-1c01-4d197ea57a33"/>
<resource>
<Observation>
<!-- compoundingAssayPost1 -->
<id value="9c56948a-3a49-6619-1c01-4d197ea57a33"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="9c56948a-3a49-6619-1c01-4d197ea57a33"> </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 "9c56948a-3a49-6619-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_fd17b5d5-9fe1-91c2-2d06-47cb5b295e73">See above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay (Post dilution bulk solution) (mg/mL) <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>#Assay (Post dilution bulk solution) (mg/mL))</span></p><p><b>subject</b>: <a href="#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 20.1 mg/mL<span style="background: LightGoldenRodYellow"> (Details: UCUM code mg/mL = 'mg/mL')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/compoundingAssayPost -->
<reference
value="ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Assay (Post dilution bulk solution) (mg/mL)"/>
<display value="Assay (Post dilution bulk solution) (mg/mL)"/>
</coding>
<text value="Assay (Post dilution bulk solution) (mg/mL)"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference value="Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="20.1"/>
<unit value="mg/mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg/mL"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9c56958a-4a39-6619-1c01-4d197ea57a33"/>
<resource>
<Observation>
<!-- compoundingAssayPost2 -->
<id value="9c56958a-4a39-6619-1c01-4d197ea57a33"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="9c56958a-4a39-6619-1c01-4d197ea57a33"> </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 "9c56958a-4a39-6619-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_fd17b5d5-9fe1-91c2-2d06-47cb5b295e73">See above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay (Post dilution bulk solution) (mg/mL) <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>#Assay (Post dilution bulk solution) (mg/mL))</span></p><p><b>subject</b>: <a href="#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 20.2 mg/mL<span style="background: LightGoldenRodYellow"> (Details: UCUM code mg/mL = 'mg/mL')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/compoundingAssayPost -->
<reference
value="ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Assay (Post dilution bulk solution) (mg/mL)"/>
<display value="Assay (Post dilution bulk solution) (mg/mL)"/>
</coding>
<text value="Assay (Post dilution bulk solution) (mg/mL)"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-2 -->
<reference value="Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="20.2"/>
<unit value="mg/mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg/mL"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9c56948a-5a39-6709-1c01-4d197ea57a33"/>
<resource>
<Observation>
<!-- compoundingAssayPost3 -->
<id value="9c56948a-5a39-6709-1c01-4d197ea57a33"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="9c56948a-5a39-6709-1c01-4d197ea57a33"> </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 "9c56948a-5a39-6709-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_fd17b5d5-9fe1-91c2-2d06-47cb5b295e73">See above (ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay (Post dilution bulk solution) (mg/mL) <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>#Assay (Post dilution bulk solution) (mg/mL))</span></p><p><b>subject</b>: <a href="#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 20.3 mg/mL<span style="background: LightGoldenRodYellow"> (Details: UCUM code mg/mL = 'mg/mL')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/compoundingAssayPost -->
<reference
value="ObservationDefinition/fd17b5d5-9fe1-91c2-2d06-47cb5b295e73"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Assay (Post dilution bulk solution) (mg/mL)"/>
<display value="Assay (Post dilution bulk solution) (mg/mL)"/>
</coding>
<text value="Assay (Post dilution bulk solution) (mg/mL)"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-3 -->
<reference value="Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="20.3"/>
<unit value="mg/mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg/mL"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9c56948a-1a39-6609-1c01-4d197ea57a33"/>
<resource>
<Observation>
<!-- observationAssay -->
<id value="9c56948a-1a39-6609-1c01-4d197ea57a33"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="9c56948a-1a39-6609-1c01-4d197ea57a33"> </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 "9c56948a-1a39-6609-1c01-4d197ea57a33" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d045e">See above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <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>#ASSAY)</span></p><p><b>subject</b>: <a href="#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 103 %<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Assay -->
<reference
value="ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
<text value="Assay"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference value="Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="103"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:1e20aed7-7626-1664-8d96-235f860d9a2c"/>
<resource>
<Observation>
<!-- observationAssay2 -->
<id value="1e20aed7-7626-1664-8d96-235f860d9a2c"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="1e20aed7-7626-1664-8d96-235f860d9a2c"> </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 "1e20aed7-7626-1664-8d96-235f860d9a2c" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d045e">See above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <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>#ASSAY)</span></p><p><b>subject</b>: <a href="#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 102 %<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Assay -->
<reference
value="ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
<text value="Assay"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-2 -->
<reference value="Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="102"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:ec6d7e30-4d70-491b-0669-a613eedd3c60"/>
<resource>
<Observation>
<!-- observationAssay3 -->
<id value="ec6d7e30-4d70-491b-0669-a613eedd3c60"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="ec6d7e30-4d70-491b-0669-a613eedd3c60"> </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 "ec6d7e30-4d70-491b-0669-a613eedd3c60" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d045e">See above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <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>#ASSAY)</span></p><p><b>subject</b>: <a href="#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 101 %<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Assay -->
<reference
value="ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
<text value="Assay"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-3 -->
<reference value="Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="101"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:ab7997fa-7b46-1175-3f01-6f6997f7878a"/>
<resource>
<Observation>
<!-- observationDegradation-imp1 -->
<id value="ab7997fa-7b46-1175-3f01-6f6997f7878a"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="ab7997fa-7b46-1175-3f01-6f6997f7878a"> </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 "ab7997fa-7b46-1175-3f01-6f6997f7878a" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</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_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % 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></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
</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/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.1"/>
<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>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:4052f28b-64a2-392d-35e4-ec8e912434d2"/>
<resource>
<Observation>
<!-- observationDegradation-imp1-2 -->
<id value="4052f28b-64a2-392d-35e4-ec8e912434d2"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="4052f28b-64a2-392d-35e4-ec8e912434d2"> </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 "4052f28b-64a2-392d-35e4-ec8e912434d2" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</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_a9dfda53-734b-045f-7ae4-94a6281d53bc">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % 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></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
</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/a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.2"/>
<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>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:34ebc51d-8105-0589-3c8d-e7aa6bd0a06c"/>
<resource>
<Observation>
<!-- observationDegradation-imp1-3 -->
<id value="34ebc51d-8105-0589-3c8d-e7aa6bd0a06c"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="34ebc51d-8105-0589-3c8d-e7aa6bd0a06c"> </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 "34ebc51d-8105-0589-3c8d-e7aa6bd0a06c" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</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_c6f5fadd-62e6-3a01-93d9-b3b182f67d06">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % 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></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
</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/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.2"/>
<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>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:2940bf11-05bf-6ce2-3c64-457d0d1f9913"/>
<resource>
<Observation>
<!-- observationDegradation-imp2 -->
<id value="2940bf11-05bf-6ce2-3c64-457d0d1f9913"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="2940bf11-05bf-6ce2-3c64-457d0d1f9913"> </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 "2940bf11-05bf-6ce2-3c64-457d0d1f9913" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</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_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % 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></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
</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/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.2"/>
<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>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:332b1e76-6f70-2b4e-5d0c-f22a0e042d3e"/>
<resource>
<Observation>
<!-- observationDegradation-imp2-2 -->
<id value="332b1e76-6f70-2b4e-5d0c-f22a0e042d3e"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="332b1e76-6f70-2b4e-5d0c-f22a0e042d3e"> </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 "332b1e76-6f70-2b4e-5d0c-f22a0e042d3e" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</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_a9dfda53-734b-045f-7ae4-94a6281d53bc">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % 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></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
</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/a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.2"/>
<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>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:f0a13a3b-2e8b-594f-6874-6050511e4c57"/>
<resource>
<Observation>
<!-- observationDegradation-imp2-3 -->
<id value="f0a13a3b-2e8b-594f-6874-6050511e4c57"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="f0a13a3b-2e8b-594f-6874-6050511e4c57"> </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 "f0a13a3b-2e8b-594f-6874-6050511e4c57" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</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_c6f5fadd-62e6-3a01-93d9-b3b182f67d06">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % 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></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
</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/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.2"/>
<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>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:7fe7ccd7-6449-0186-2282-3eeb4cf6a795"/>
<resource>
<Observation>
<!-- observationDegradation-imp3 -->
<id value="7fe7ccd7-6449-0186-2282-3eeb4cf6a795"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="7fe7ccd7-6449-0186-2282-3eeb4cf6a795"> </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 "7fe7ccd7-6449-0186-2282-3eeb4cf6a795" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</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_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % 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></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
</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/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.2"/>
<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 3"/>
</valueCodeableConcept>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:be016630-8754-7414-9014-21e020ad66c6"/>
<resource>
<Observation>
<!-- observationDegradation-imp3-2 -->
<id value="be016630-8754-7414-9014-21e020ad66c6"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="be016630-8754-7414-9014-21e020ad66c6"> </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 "be016630-8754-7414-9014-21e020ad66c6" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</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_a9dfda53-734b-045f-7ae4-94a6281d53bc">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % 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></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
</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/a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.2"/>
<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 3"/>
</valueCodeableConcept>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:92568f68-78f3-908c-6935-ff5f3d574dd6"/>
<resource>
<Observation>
<!-- observationDegradation-imp3-3 -->
<id value="92568f68-78f3-908c-6935-ff5f3d574dd6"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="92568f68-78f3-908c-6935-ff5f3d574dd6"> </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 "92568f68-78f3-908c-6935-ff5f3d574dd6" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</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_c6f5fadd-62e6-3a01-93d9-b3b182f67d06">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % 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></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
</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/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.2"/>
<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 3"/>
</valueCodeableConcept>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12"/>
<resource>
<Observation>
<!-- observationDegradation-imp-unspecified -->
<id value="a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12"> </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 "a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</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_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % 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>Individual unspecified degradation products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
</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/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.1"/>
<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="Individual unspecified degradation products"/>
</valueCodeableConcept>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:d8533dcb-03f8-5997-6ccf-4f9b6f7a5745"/>
<resource>
<Observation>
<!-- observationDegradation-imp-unspecified-2 -->
<id value="d8533dcb-03f8-5997-6ccf-4f9b6f7a5745"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="d8533dcb-03f8-5997-6ccf-4f9b6f7a5745"> </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 "d8533dcb-03f8-5997-6ccf-4f9b6f7a5745" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</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_a9dfda53-734b-045f-7ae4-94a6281d53bc">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % 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>Individual unspecified degradation products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
</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/a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.1"/>
<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="Individual unspecified degradation products"/>
</valueCodeableConcept>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:7cec19a2-34a7-6b80-3d60-083b2cc64fcb"/>
<resource>
<Observation>
<!-- observationDegradation-imp-unspecified-3 -->
<id value="7cec19a2-34a7-6b80-3d60-083b2cc64fcb"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="7cec19a2-34a7-6b80-3d60-083b2cc64fcb"> </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 "7cec19a2-34a7-6b80-3d60-083b2cc64fcb" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</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_c6f5fadd-62e6-3a01-93d9-b3b182f67d06">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % 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>Individual unspecified degradation products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
</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/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.1"/>
<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="Individual unspecified degradation products"/>
</valueCodeableConcept>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:27aa47fd-7964-4f96-6495-b2bec7f160e7"/>
<resource>
<Observation>
<!-- observationDegradation-imp-total -->
<id value="27aa47fd-7964-4f96-6495-b2bec7f160e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="27aa47fd-7964-4f96-6495-b2bec7f160e7"> </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 "27aa47fd-7964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</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_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.6 % 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 products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
</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/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.6"/>
<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="Total degradation products"/>
</valueCodeableConcept>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:6a78bcde-4781-226c-946e-a4b6915c1899"/>
<resource>
<Observation>
<!-- observationDegradation-imp-total-2 -->
<id value="6a78bcde-4781-226c-946e-a4b6915c1899"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="6a78bcde-4781-226c-946e-a4b6915c1899"> </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 "6a78bcde-4781-226c-946e-a4b6915c1899" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</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_a9dfda53-734b-045f-7ae4-94a6281d53bc">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.7 % 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 products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
</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/a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.7"/>
<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="Total degradation products"/>
</valueCodeableConcept>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:f9f11088-7527-947c-3d3f-e71b32e13c78"/>
<resource>
<Observation>
<!-- observationDegradation-imp-total-3 -->
<id value="f9f11088-7527-947c-3d3f-e71b32e13c78"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="f9f11088-7527-947c-3d3f-e71b32e13c78"> </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 "f9f11088-7527-947c-3d3f-e71b32e13c78" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_8bdea820-4197-7c7d-0990-7be06bf78aaf">See above (ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf)</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_c6f5fadd-62e6-3a01-93d9-b3b182f67d06">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.6 % 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 products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Degradation -->
<reference
value="ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf"/>
</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/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.6"/>
<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="Total degradation products"/>
</valueCodeableConcept>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:66c2f585-678e-78b8-2235-1a3b37bd6e46"/>
<resource>
<Observation>
<!-- observationWater -->
<id value="66c2f585-678e-78b8-2235-1a3b37bd6e46"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="66c2f585-678e-78b8-2235-1a3b37bd6e46"> </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 "66c2f585-678e-78b8-2235-1a3b37bd6e46" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_31e29d22-5fcb-546e-24fd-52a4a4004467">See above (ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467)</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_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.5 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Water -->
<reference
value="ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467"/>
</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>
<text value="Water Content"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference value="Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.5"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:f8232d25-023d-679f-9c58-a6dc234b7a28"/>
<resource>
<Observation>
<!-- observationWater2 -->
<id value="f8232d25-023d-679f-9c58-a6dc234b7a28"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="f8232d25-023d-679f-9c58-a6dc234b7a28"> </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 "f8232d25-023d-679f-9c58-a6dc234b7a28" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_31e29d22-5fcb-546e-24fd-52a4a4004467">See above (ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467)</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_a9dfda53-734b-045f-7ae4-94a6281d53bc">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.5 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Water -->
<reference
value="ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467"/>
</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>
<text value="Water Content"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-2 -->
<reference value="Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.5"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:368b82be-75dd-1d97-3dbc-a7eed9869daa"/>
<resource>
<Observation>
<!-- observationWater3 -->
<id value="368b82be-75dd-1d97-3dbc-a7eed9869daa"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="368b82be-75dd-1d97-3dbc-a7eed9869daa"> </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 "368b82be-75dd-1d97-3dbc-a7eed9869daa" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_31e29d22-5fcb-546e-24fd-52a4a4004467">See above (ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467)</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_c6f5fadd-62e6-3a01-93d9-b3b182f67d06">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.5 % w/w<span style="background: LightGoldenRodYellow"> (Details: UCUM code % = '%')</span></p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/Water -->
<reference
value="ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467"/>
</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>
<text value="Water Content"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-3 -->
<reference value="Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="0.5"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:44aa47fd-8964-4f96-6495-b2bec7f160e7"/>
<resource>
<Observation>
<!-- fillingTAMC1 -->
<id value="44aa47fd-8964-4f96-6495-b2bec7f160e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="44aa47fd-8964-4f96-6495-b2bec7f160e7"> </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 "44aa47fd-8964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_64505a3c-5034-448a-9c19-938ce1958424">See above (ObservationDefinition/64505a3c-5034-448a-9c19-938ce1958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: TAMC <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>#TAMC)</span></p><p><b>subject</b>: <a href="#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 9.1 CFU/100ml</p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/TAMC -->
<reference
value="ObservationDefinition/64505a3c-5034-448a-9c19-938ce1958424"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="TAMC"/>
<display value="TAMC"/>
</coding>
<text value="TAMC"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference value="Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<!-- todo UCUM -->
<valueQuantity>
<value value="9.1"/>
<unit value="CFU/100ml"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:45aa47fd-8964-4f96-6495-b2bec7f160e7"/>
<resource>
<Observation>
<!-- fillingConclusion-nosubject -->
<id value="45aa47fd-8964-4f96-6495-b2bec7f160e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="45aa47fd-8964-4f96-6495-b2bec7f160e7"> </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 "45aa47fd-8964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_22515a3c-5034-448a-9c19-938ce1958424">See above (ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: Conclusion <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>#CONC)</span></p><p><b>subject</b>: <span>: all batches</span></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Conclusion of filling tests....</p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/conclusion -->
<reference
value="ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="CONC"/>
<display value="Conclusion"/>
</coding>
<text value="Conclusion"/>
</code>
<!-- no subject because it applies to all the samples -->
<subject>
<extension
url="http://hl7.org/fhir/StructureDefinition/data-absent-reason">
<valueCode value="unsupported"/>
</extension>
<display value="all batches"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueString value="Conclusion of filling tests...."/>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:45ab47fd-8964-4f96-6495-b2bec7f160e7"/>
<resource>
<Observation>
<!-- no subject -->
<!-- lyophilizationConclusion-nosubject -->
<id value="45ab47fd-8964-4f96-6495-b2bec7f160e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="45ab47fd-8964-4f96-6495-b2bec7f160e7"> </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 "45ab47fd-8964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_22525a3c-5034-448a-9c19-938ce1958424">See above (ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: Conclusion <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>#CONC)</span></p><p><b>subject</b>: <span>: all batches</span></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Conclusion of lyophilization tests....</p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/LyophilizationConclusion -->
<reference
value="ObservationDefinition/22525a3c-5034-448a-9c19-938ce1958424"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="CONC"/>
<display value="Conclusion"/>
</coding>
<text value="Conclusion"/>
</code>
<!-- no subject because it applies to all the samples -->
<subject>
<extension
url="http://hl7.org/fhir/StructureDefinition/data-absent-reason">
<valueCode value="unsupported"/>
</extension>
<display value="all batches"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueString value="Conclusion of lyophilization tests...."/>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:37aa47fd-8964-4f96-6495-b2bec7f160e7"/>
<resource>
<Observation>
<!-- lyophilizerNumber1 -->
<id value="37aa47fd-8964-4f96-6495-b2bec7f160e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="37aa47fd-8964-4f96-6495-b2bec7f160e7"> </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 "37aa47fd-8964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_64535a3c-5334-448a-9c29-938ce2958424">See above (ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <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>#Lyophilizer Number "Lyophilizer Number")</span></p><p><b>subject</b>: <a href="#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 1234</p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/LyophilizerNumber -->
<reference
value="ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Lyophilizer Number"/>
<display value="Lyophilizer Number"/>
</coding>
<text value="Assay"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference value="Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="1234"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:38aa47fd-8964-4f96-6495-b2bec7f160e7"/>
<resource>
<Observation>
<!-- lyophilizerNumber2 -->
<id value="38aa47fd-8964-4f96-6495-b2bec7f160e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="38aa47fd-8964-4f96-6495-b2bec7f160e7"> </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 "38aa47fd-8964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_64535a3c-5334-448a-9c29-938ce2958424">See above (ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <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>#Lyophilizer Number "Lyophilizer Number")</span></p><p><b>subject</b>: <a href="#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 1235</p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/LyophilizerNumber -->
<reference
value="ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Lyophilizer Number"/>
<display value="Lyophilizer Number"/>
</coding>
<text value="Assay"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-2 -->
<reference value="Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="1235"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:38aa48fd-8964-4f96-6495-b2bec7f160e7"/>
<resource>
<Observation>
<!-- lyophilizerNumber3 -->
<id value="38aa48fd-8964-4f96-6495-b2bec7f160e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="38aa48fd-8964-4f96-6495-b2bec7f160e7"> </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 "38aa48fd-8964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_64535a3c-5334-448a-9c29-938ce2958424">See above (ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <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>#Lyophilizer Number "Lyophilizer Number")</span></p><p><b>subject</b>: <a href="#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 1236</p></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/LyophilizerNumber -->
<reference
value="ObservationDefinition/64535a3c-5334-448a-9c29-938ce2958424"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Lyophilizer Number"/>
<display value="Lyophilizer Number"/>
</coding>
<text value="Assay"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-3 -->
<reference value="Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="1236"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:37aa47fd-7964-4f96-6495-b2bec7f160e7"/>
<resource>
<Observation>
<!-- lyophilizationAssay1 -->
<id value="37aa47fd-7964-4f96-6495-b2bec7f160e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="37aa47fd-7964-4f96-6495-b2bec7f160e7"> </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 "37aa47fd-7964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_22e7e672-40a6-4036-3c1f-b8ba6a7d045e">See above (ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <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>#ASSAY)</span></p><p><b>subject</b>: <a href="#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 97 %<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>Number of Locations <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>#LOC)</span></td><td>3</td></tr></table></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/LyophilizationAssay -->
<reference
value="ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
<text value="Assay"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference value="Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="97"/>
<unit value="%"/>
<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="LOC"/>
<display value="Number of Locations"/>
</coding>
</code>
<valueInteger value="3"/>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:47aa47fd-7964-4f96-6495-b2bec7f160e7"/>
<resource>
<Observation>
<!-- lyophilizationAssay2 -->
<id value="47aa47fd-7964-4f96-6495-b2bec7f160e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="47aa47fd-7964-4f96-6495-b2bec7f160e7"> </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 "47aa47fd-7964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_22e7e672-40a6-4036-3c1f-b8ba6a7d045e">See above (ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <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>#ASSAY)</span></p><p><b>subject</b>: <a href="#Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc">See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 98 %<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>Number of Locations <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>#LOC)</span></td><td>4</td></tr></table></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/LyophilizationAssay -->
<reference
value="ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
<text value="Assay"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-2 -->
<reference value="Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="98"/>
<unit value="%"/>
<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="LOC"/>
<display value="Number of Locations"/>
</coding>
</code>
<valueInteger value="4"/>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:47aa47fd-7964-4f96-6495-b2bec7f160e8"/>
<resource>
<Observation>
<!-- lyophilizationAssay3 -->
<id value="47aa47fd-7964-4f96-6495-b2bec7f160e8"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="47aa47fd-7964-4f96-6495-b2bec7f160e8"> </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 "47aa47fd-7964-4f96-6495-b2bec7f160e8" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_22e7e672-40a6-4036-3c1f-b8ba6a7d045e">See above (ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <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>#ASSAY)</span></p><p><b>subject</b>: <a href="#Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06">See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 96 %<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>Number of Locations <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>#LOC)</span></td><td>2</td></tr></table></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/LyophilizationAssay -->
<reference
value="ObservationDefinition/22e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
<text value="Assay"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-3 -->
<reference value="Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<valueQuantity>
<value value="96"/>
<unit value="%"/>
<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="LOC"/>
<display value="Number of Locations"/>
</coding>
</code>
<valueInteger value="2"/>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:47aa47fd-8964-4f96-6495-b2bec7f160e7"/>
<resource>
<Observation>
<!-- lyophilizerWaterHomogeneity1 -->
<id value="47aa47fd-8964-4f96-6495-b2bec7f160e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="47aa47fd-8964-4f96-6495-b2bec7f160e7"> </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 "47aa47fd-8964-4f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_32e29d22-6fcb-546e-24fd-52a4a4004467">See above (ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467)</a></p><p><b>status</b>: final</p><p><b>code</b>: Lyophilization Water Homogeneity <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>#Lyophilization Water Homogeneity)</span></p><p><b>subject</b>: <a href="#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><blockquote><p><b>component</b></p><p><b>code</b>: Do statistically significant effects <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>#SSE "Statistically significant effects")</span></p><p><b>value</b>: Yes</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Lower one-sided 95% confidence limit of Max Difference <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>#LCL)</span></p><p><b>value</b>: 0.8 %</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Upper one-sided 95% confidence limit of Max Difference <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>#UCL)</span></p><p><b>value</b>: 0.9 %</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Was Homogeneity demonstrated? <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>#Homogeneity "Homogeneity demonstrated")</span></p><p><b>value</b>: Yes</p></blockquote></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/LyophilizationWaterHomogeneity -->
<reference
value="ObservationDefinition/32e29d22-6fcb-546e-24fd-52a4a4004467"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Lyophilization Water Homogeneity"/>
<display value="Lyophilization Water Homogeneity"/>
</coding>
<text value="Lyophilization Water Homogeneity"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference value="Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="SSE"/>
<display value="Statistically significant effects"/>
</coding>
<text value="Do statistically significant effects"/>
</code>
<valueString value="Yes"/>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="LCL"/>
<display
value="Lower one-sided 95% confidence limit of Max Difference"/>
</coding>
</code>
<valueQuantity>
<value value="0.8"/>
<unit value="%"/>
</valueQuantity>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="UCL"/>
<display
value="Upper one-sided 95% confidence limit of Max Difference"/>
</coding>
<text
value="Upper one-sided 95% confidence limit of Max Difference"/>
</code>
<valueQuantity>
<value value="0.9"/>
<unit value="%"/>
</valueQuantity>
</component>
<!-- boolean? -->
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Homogeneity"/>
<display value="Homogeneity demonstrated"/>
</coding>
<text value="Was Homogeneity demonstrated?"/>
</code>
<valueString value="Yes"/>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:47aa47fd-8964-5f96-6495-b2bec7f160e7"/>
<resource>
<Observation>
<!-- lyophilizerAssayHomogeneity1 -->
<id value="47aa47fd-8964-5f96-6495-b2bec7f160e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="47aa47fd-8964-5f96-6495-b2bec7f160e7"> </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 "47aa47fd-8964-5f96-6495-b2bec7f160e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_32e29d32-6fcb-546e-24fd-52a4a4004467">See above (ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467)</a></p><p><b>status</b>: final</p><p><b>code</b>: Lyophilization Assay Homogeneity <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>#Lyophilization Assay Homogeneity)</span></p><p><b>subject</b>: <a href="#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><blockquote><p><b>component</b></p><p><b>code</b>: Do statistically significant effects <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>#SSE "Statistically significant effects")</span></p><p><b>value</b>: No</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Lower one-sided 95% confidence limit of Max Difference <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>#LCL)</span></p><p><b>value</b>: Not calculated</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Upper one-sided 95% confidence limit of Max Difference <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>#UCL)</span></p><p><b>value</b>: Not calculated</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Was Homogeneity demonstrated? <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>#Homogeneity "Homogeneity demonstrated")</span></p><p><b>value</b>: Yes</p></blockquote></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/LyophilizationAssayHomogeneity -->
<reference
value="ObservationDefinition/32e29d32-6fcb-546e-24fd-52a4a4004467"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Lyophilization Assay Homogeneity"/>
<display value="Lyophilization Assay Homogeneity"/>
</coding>
<text value="Lyophilization Assay Homogeneity"/>
</code>
<subject>
<!-- Medication/medication-batch-information-drug-pq-ex1 -->
<reference value="Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
</performer>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="SSE"/>
<display value="Statistically significant effects"/>
</coding>
<text value="Do statistically significant effects"/>
</code>
<valueString value="No"/>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="LCL"/>
<display
value="Lower one-sided 95% confidence limit of Max Difference"/>
</coding>
</code>
<valueString value="Not calculated"/>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="UCL"/>
<display
value="Upper one-sided 95% confidence limit of Max Difference"/>
</coding>
<text
value="Upper one-sided 95% confidence limit of Max Difference"/>
</code>
<valueString value="Not calculated"/>
</component>
<!-- boolean? -->
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Homogeneity"/>
<display value="Homogeneity demonstrated"/>
</coding>
<text value="Was Homogeneity demonstrated?"/>
</code>
<valueString value="Yes"/>
</component>
</Observation>
</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>
<!-- medicinalproductdefinition-drug-product-pq-ex1 -->
<id value="a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
<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></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>
<!-- productIngredient -->
<id value="a0694a7a-aafa-4cbe-8135-c788a9a4d3d6"/>
<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></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_6eb94d34-48b4-5bb0-4c05-e183d2ea3e95">See above (SubstanceDefinition/6eb94d34-48b4-5bb0-4c05-e183d2ea3e95)</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/substance1 -->
<reference
value="SubstanceDefinition/6eb94d34-48b4-5bb0-4c05-e183d2ea3e95"/>
</reference>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:6eb94d34-48b4-5bb0-4c05-e183d2ea3e95"/>
<resource>
<SubstanceDefinition>
<!-- substance1 -->
<id value="6eb94d34-48b4-5bb0-4c05-e183d2ea3e95"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="6eb94d34-48b4-5bb0-4c05-e183d2ea3e95"> </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 "6eb94d34-48b4-5bb0-4c05-e183d2ea3e95" </p></div><p><b>manufacturer</b>: <a href="#Organization_23dbbd32-2962-9fc3-40b1-67e864f21cd2">See above (Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2)</a></p><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td></tr><tr><td style="display: none">*</td><td>Stelbatolol</td></tr></table></div>
</text>
<manufacturer>
<!-- Organization/substance-manufacturer -->
<reference
value="Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2"/>
</manufacturer>
<name>
<name value="Stelbatolol"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:23dbbd32-2962-9fc3-40b1-67e864f21cd2"/>
<resource>
<Organization>
<!-- substance-manufacturer -->
<id value="23dbbd32-2962-9fc3-40b1-67e864f21cd2"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="23dbbd32-2962-9fc3-40b1-67e864f21cd2"> </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 "23dbbd32-2962-9fc3-40b1-67e864f21cd2" </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: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>
<!-- manufacturing plan -->
<entry>
<fullUrl value="urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a"/>
<!-- another outer action can be the whole thing, if needed -->
<!-- removed the main actions for brevity (see manufacturing example) -->
<resource>
<PlanDefinition>
<id value="plandefinition-drug-pq-ex2-manufacturing-plan"/>
<!-- indicate this is as subset of the resource. In practice it would have it all -->
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"/>
<tag>
<system
value="http://terminology.hl7.org/CodeSystem/v3-ObservationValue"/>
<code value="SUBSETTED"/>
</tag>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PlanDefinition</b><a name="plandefinition-drug-pq-ex2-manufacturing-plan"> </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 "plandefinition-drug-pq-ex2-manufacturing-plan" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PlanDefinition-drug-pq.html">PlanDefinition - Drug PQ</a></p><p style="margin-bottom: 0px">Tag: <span title="{http://terminology.hl7.org/CodeSystem/v3-ObservationValue http://terminology.hl7.org/CodeSystem/v3-ObservationValue}">http://terminology.hl7.org/CodeSystem/v3-ObservationValue</span></p></div><p><b>Extension - History of Process PQ</b>: This can be text about the history</p><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a</code></p><p><b>title</b>: Process 1.0</p><p><b>type</b>: Workflow Definition <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-plan-definition-type.html">PlanDefinitionType</a>#workflow-definition; <a href="CodeSystem-cs-planType-local-pq.html">CodeSystem - Plan Type</a>#manufacturing-process "Manufacturing Process")</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 manufacturing process (5)</p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-pH</blockquote><p><b>category</b>: Physical Property <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-testCategory-local-pq.html">CodeSystem - Test Category</a>#C123456)</span></p><p><b>description</b>: Controls - pH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>priority</b>: Critical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-goalPriority-local-pq.html">CodeSystem - Goal Priority</a>#critical)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>pH must be in range 6.9 to 7.1 <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>#pH "pH")</span></td><td>6.9-7.1 pH</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-water-content</blockquote><p><b>category</b>: Physical Property <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-testCategory-local-pq.html">CodeSystem - Test Category</a>#C123456)</span></p><p><b>description</b>: Controls - Water Content <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>priority</b>: Critical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-goalPriority-local-pq.html">CodeSystem - Goal Priority</a>#critical)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Under 2% <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 "Water content")</span></td><td>?-2</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-particle-size</blockquote><p><b>category</b>: Physical Property <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-testCategory-local-pq.html">CodeSystem - Test Category</a>#C123456)</span></p><p><b>description</b>: Controls - Particle Size <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>priority</b>: Critical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-goalPriority-local-pq.html">CodeSystem - Goal Priority</a>#critical)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Under 200 microns <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>#particle-size "Particle Size")</span></td><td>?-200</td></tr></table></blockquote><blockquote><p><b>actor</b></p><h3>Options</h3><table class="grid"><tr><td style="display: none">-</td><td><b>TypeReference</b></td><td><b>Role</b></td></tr><tr><td style="display: none">*</td><td><a href="#DeviceDefinition_82a39a18-91cf-a29d-76c1-a9e8bad9494d">See above (DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d)</a></td><td>Mixing Vessel <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-equipmentClass-local-pq.html">CodeSystem - Equipment Class</a>#mixing-vessel)</span></td></tr></table></blockquote><blockquote><p><b>actor</b></p><h3>Options</h3><table class="grid"><tr><td style="display: none">-</td><td><b>TypeReference</b></td><td><b>Role</b></td></tr><tr><td style="display: none">*</td><td><a href="#DeviceDefinition_82a39a18-91cf-b29d-76c1-a9e8bad9494d">See above (DeviceDefinition/82a39a18-91cf-b29d-76c1-a9e8bad9494d)</a></td><td>Receiving Vessel <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-equipmentClass-local-pq.html">CodeSystem - Equipment Class</a>#receiving-vessel)</span></td></tr></table></blockquote></div>
</text>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq">
<valueMarkdown value="This can be text about the history"/>
</extension>
<!-- http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a -->
<url
value="http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a"/>
<title value="Process 1.0"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/plan-definition-type"/>
<code value="workflow-definition"/>
<display value="Workflow Definition"/>
</coding>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-planType-local-pq"/>
<code value="manufacturing-process"/>
<display value="Manufacturing Process"/>
</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 manufacturing process (5)"/>
<goal id="goal-control-pH">
<category>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq"/>
<code value="C123456"/>
<display value="Physical Property"/>
</coding>
</category>
<!-- this is mandatory, even though we don't really want it -->
<description>
<text value="Controls - pH"/>
</description>
<priority>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-local-pq"/>
<code value="critical"/>
<display value="Critical"/>
</coding>
</priority>
<target>
<measure>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="pH"/>
<display value="pH"/>
</coding>
<text value="pH must be in range 6.9 to 7.1"/>
</measure>
<!-- detailString value="can also be a string" -->
<detailRange>
<low>
<value value="6.9"/>
<unit value="pH"/>
</low>
<high>
<value value="7.1"/>
<unit value="pH"/>
</high>
</detailRange>
</target>
</goal>
<goal id="goal-control-water-content">
<category>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq"/>
<code value="C123456"/>
<display value="Physical Property"/>
</coding>
</category>
<!-- this is mandatory, even though we don't really want it -->
<description>
<text value="Controls - Water Content"/>
</description>
<priority>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-local-pq"/>
<code value="critical"/>
<display value="Critical"/>
</coding>
</priority>
<target>
<measure>
<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="Under 2%"/>
</measure>
<!-- detailString value="can also be a string" -->
<detailRange>
<high>
<value value="2"/>
<unit value="%"/>
</high>
</detailRange>
</target>
</goal>
<goal id="goal-control-particle-size">
<category>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq"/>
<code value="C123456"/>
<display value="Physical Property"/>
</coding>
</category>
<description>
<text value="Controls - Particle Size"/>
</description>
<priority>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-local-pq"/>
<code value="critical"/>
<display value="Critical"/>
</coding>
</priority>
<target>
<measure>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="particle-size"/>
<display value="Particle Size"/>
</coding>
<text value="Under 200 microns"/>
</measure>
<!-- detailString value="can also be a string" -->
<detailRange>
<high>
<value value="200"/>
<unit value="microns"/>
</high>
</detailRange>
</target>
</goal>
<actor>
<option>
<typeReference>
<!-- DeviceDefinition/mixing-vessel -->
<reference
value="DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d"/>
</typeReference>
<role>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-equipmentClass-local-pq"/>
<code value="mixing-vessel"/>
<display value="Mixing Vessel"/>
</coding>
</role>
</option>
</actor>
<actor>
<option>
<typeReference>
<!-- DeviceDefinition/receiving-tank -->
<reference
value="DeviceDefinition/82a39a18-91cf-b29d-76c1-a9e8bad9494d"/>
</typeReference>
<role>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-equipmentClass-local-pq"/>
<code value="receiving-vessel"/>
<display value="Receiving Vessel"/>
</coding>
</role>
</option>
</actor>
</PlanDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:82a39a18-91cf-a29d-76c1-a9e8bad9494d"/>
<resource>
<DeviceDefinition>
<!-- mixing-vessel -->
<id value="82a39a18-91cf-a29d-76c1-a9e8bad9494d"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: DeviceDefinition</b><a name="82a39a18-91cf-a29d-76c1-a9e8bad9494d"> </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 DeviceDefinition "82a39a18-91cf-a29d-76c1-a9e8bad9494d" </p></div><h3>DeviceNames</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>Mixing Vessel</td><td>registered-name</td></tr></table><h3>Classifications</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>Mixing Vessel <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-deviceType-local-pq.html">CodeSystem - Device Type</a>#mixing-vessel)</span></td></tr></table><h3>Properties</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Capacity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-deviceProperty-local-pq.html">CodeSystem - Device Property</a>#Capacity)</span></td><td>1000 litres</td></tr></table></div>
</text>
<deviceName>
<name value="Mixing Vessel"/>
<type value="registered-name"/>
</deviceName>
<classification>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceType-local-pq"/>
<code value="mixing-vessel"/>
<display value="Mixing Vessel"/>
</coding>
</type>
</classification>
<property>
<type>
<!-- seems a little different to "maximum capacity -->
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceProperty-local-pq"/>
<code value="Capacity"/>
<display value="Capacity"/>
</coding>
</type>
<valueQuantity>
<value value="1000"/>
<unit value="litres"/>
</valueQuantity>
</property>
</DeviceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:82a39a18-91cf-b29d-76c1-a9e8bad9494d"/>
<resource>
<DeviceDefinition>
<!-- receiving-tank -->
<id value="82a39a18-91cf-b29d-76c1-a9e8bad9494d"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: DeviceDefinition</b><a name="82a39a18-91cf-b29d-76c1-a9e8bad9494d"> </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 DeviceDefinition "82a39a18-91cf-b29d-76c1-a9e8bad9494d" </p></div><h3>DeviceNames</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>Receiving Tank</td><td>registered-name</td></tr></table><h3>Classifications</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>Receiving Tank <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-deviceType-local-pq.html">CodeSystem - Device Type</a>#receiving-tank)</span></td></tr></table><h3>Properties</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Capacity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-deviceProperty-local-pq.html">CodeSystem - Device Property</a>#Capacity)</span></td><td>1200 litres</td></tr></table></div>
</text>
<deviceName>
<name value="Receiving Tank"/>
<type value="registered-name"/>
</deviceName>
<classification>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceType-local-pq"/>
<code value="receiving-tank"/>
<display value="Receiving Tank"/>
</coding>
</type>
</classification>
<property>
<type>
<!-- seems a little different to "maximum capacity -->
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceProperty-local-pq"/>
<code value="Capacity"/>
<display value="Capacity"/>
</coding>
</type>
<valueQuantity>
<value value="1200"/>
<unit value="litres"/>
</valueQuantity>
</property>
</DeviceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b"/>
<resource>
<Substance>
<!-- <id value="actual-batch-substance"/> -->
<!-- substance-drug-pq-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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