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
<Bundle xmlns="http://hl7.org/fhir">
<!-- Product compatibility -->
<id value="bundle-drug-product-compatibility-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-compatibility-pq"/>
</meta>
<type value="collection"/>
<entry>
<fullUrl value="urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f"/>
<resource>
<PlanDefinition>
<!-- id value="validationProtocol"/ -->
<!-- plandefinition-compatibility -->
<id value="2038e4c7-22b8-4c56-2d28-6c077648763f"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PlanDefinition</b><a name="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><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PlanDefinition-drug-pq.html">PlanDefinition - Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f</code></p><p><b>title</b>: Drug Product Compatibility</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>#product-compatibility "Product Compatibility")</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>: Results From Evaluation of Drug Product Compatibility With the Glass Syringe Using the Autoinjector/Pen</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>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><code>ObservationDefinition/64525a3d-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/64525a33-5034-448a-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/54bb47fd-8964-4f96-6495-b2bec7f161e8</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/74525a3d-5034-448a-9c19-938ce1958424</code></td></tr></table></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="Drug Product Compatibility"/>
<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="product-compatibility"/>
<display value="Product Compatibility"/>
</coding>
</type>
<status value="active"/>
<subjectReference>
<!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-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="Results From Evaluation of Drug Product Compatibility With the Glass Syringe Using the Autoinjector/Pen"/>
<!-- needs some other code -->
<!-- code>
<coding>
<system value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"/>
<code value="FilteredFormulatedDrugProductPerformanceIndicatorResultsStep"/>
<display value="Filtered Formulated Drug Product Performance Indicator Results"/>
</coding>
</code -->
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/SE-UHPLCMainPeak -->
<definitionCanonical
value="ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/SE-UHPLCHMW -->
<definitionCanonical
value="ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/CEX-HPLCAcidicPeak -->
<definitionCanonical
value="ObservationDefinition/54bb47fd-8964-4f96-6495-b2bec7f161e8"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/CEX-HPLCMainPeak -->
<definitionCanonical
value="ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958424"/>
</action>
</action>
</PlanDefinition>
</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 -->
<!-- no subject -->
<!-- processValidationReport -->
<id value="b664977d-799d-a1ce-928a-5def2a9955bd"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: DiagnosticReport</b><a name="b664977d-799d-a1ce-928a-5def2a9955bd"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource DiagnosticReport "b664977d-799d-a1ce-928a-5def2a9955bd" </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>: Product Compatibility Report <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-reportType-local-pq.html">CodeSystem - Report Type</a>#Product Compatibility Report)</span></p><p><b>effective</b>: 2020-12</p><p><b>result</b>: </p><ul><li><a href="#Observation_44ba47fd-8964-4f96-6495-b2bec7f161e7">See above (Observation/44ba47fd-8964-4f96-6495-b2bec7f161e7)</a></li><li><a href="#Observation_54ca47fd-8964-4f96-6495-b2bec7f162e7">See above (Observation/54ca47fd-8964-4f96-6495-b2bec7f162e7)</a></li><li><a href="#Observation_44ba47fd-8964-4f97-6495-b2bec7f161e7">See above (Observation/44ba47fd-8964-4f97-6495-b2bec7f161e7)</a></li><li><a href="#Observation_54ca47fd-8964-4f98-6495-b2bec7f162e7">See above (Observation/54ca47fd-8964-4f98-6495-b2bec7f162e7)</a></li><li><a href="#Observation_54ba47fd-8964-4f96-6495-b2bec7f161e8">See above (Observation/54ba47fd-8964-4f96-6495-b2bec7f161e8)</a></li><li><a href="#Observation_54ba48fd-8964-4f96-6495-b2bec7f161e7">See above (Observation/54ba48fd-8964-4f96-6495-b2bec7f161e7)</a></li><li><a href="#Observation_54ba47fd-8964-4f96-6495-b2bec7f161e7">See above (Observation/54ba47fd-8964-4f96-6495-b2bec7f161e7)</a></li><li><a href="#Observation_54bb47fd-8964-4f96-6495-b2bec7f161e7">See above (Observation/54bb47fd-8964-4f96-6495-b2bec7f161e7)</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/plandefinition-compatibility -->
<reference
value="PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f"/>
</valueReference>
</extension>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-reportType-local-pq"/>
<code value="Product Compatibility Report"/>
<display value="Product Compatibility Report"/>
</coding>
</code>
<effectiveDateTime value="2020-12"/>
<result>
<!-- Observation/SE-UHPLCMainPeak1 -->
<reference
value="Observation/44ba47fd-8964-4f96-6495-b2bec7f161e7"/>
</result>
<result>
<!-- Observation/SE-UHPLCMainPeak2 -->
<reference
value="Observation/54ca47fd-8964-4f96-6495-b2bec7f162e7"/>
</result>
<result>
<!-- Observation/SE-UHPLCHMW1 -->
<reference
value="Observation/44ba47fd-8964-4f97-6495-b2bec7f161e7"/>
</result>
<result>
<!-- Observation/SE-UHPLCHMW2 -->
<reference
value="Observation/54ca47fd-8964-4f98-6495-b2bec7f162e7"/>
</result>
<result>
<!-- Observation/CEX-Acidic-1 -->
<reference
value="Observation/54ba47fd-8964-4f96-6495-b2bec7f161e8"/>
</result>
<result>
<!-- Observation/CEX-Acidic-2 -->
<reference
value="Observation/54ba48fd-8964-4f96-6495-b2bec7f161e7"/>
</result>
<result>
<!-- Observation/CEX-HPLC-1 -->
<reference
value="Observation/54ba47fd-8964-4f96-6495-b2bec7f161e7"/>
</result>
<result>
<!-- Observation/CEX-HPLC-2 -->
<reference
value="Observation/54bb47fd-8964-4f96-6495-b2bec7f161e7"/>
</result>
<conclusion
value="The samples have been assessed and the conclusion is..."/>
</DiagnosticReport>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:64525a3d-5034-448a-9c19-938ce1958424"/>
<resource>
<ObservationDefinition>
<!-- SE-UHPLCMainPeak -->
<id value="64525a3d-5034-448a-9c19-938ce1958424"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="64525a3d-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 "64525a3d-5034-448a-9c19-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424</code></p><p><b>title</b>: SE-UHPLC % Main Peak</p><p><b>status</b>: active</p><p><b>code</b>: SE-UHPLC 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>#SE-UHPLCMainPeak "SE-UHPLC Main Peak")</span></p><blockquote><p><b>component</b></p><p><b>code</b>: SE-UHPLC Main Peak - 15 <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>#SE-UHPLCMainPeak-15)</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: SE-UHPLC Main Peak - 25 <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>#SE-UHPLCMainPeak-25)</span></p></blockquote></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424"/>
<title value="SE-UHPLC % Main Peak"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="SE-UHPLCMainPeak"/>
<display value="SE-UHPLC Main Peak"/>
</coding>
<text value="SE-UHPLC Main Peak (%)"/>
</code>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="SE-UHPLCMainPeak-15"/>
<display value="SE-UHPLC Main Peak - 15"/>
</coding>
</code>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="SE-UHPLCMainPeak-25"/>
<display value="SE-UHPLC Main Peak - 25"/>
</coding>
</code>
</component>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:64525a33-5034-448a-9c19-938ce1958424"/>
<resource>
<ObservationDefinition>
<!-- SE-UHPLCHMW -->
<id value="64525a33-5034-448a-9c19-938ce1958424"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="64525a33-5034-448a-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 "64525a33-5034-448a-9c19-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424</code></p><p><b>title</b>: SE-UHPLC % HMW</p><p><b>status</b>: active</p><p><b>code</b>: SE-UHPLC HMW (%) <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>#SE-UHPLCHMW "SE-UHPLC HMW")</span></p><blockquote><p><b>component</b></p><p><b>code</b>: SE-UHPLC HMW - 15 <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>#SE-UHPLCHMW-15)</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: SE-UHPLC HMW - 25 <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>#SE-UHPLCHMW-25)</span></p></blockquote></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424"/>
<title value="SE-UHPLC % HMW"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="SE-UHPLCHMW"/>
<display value="SE-UHPLC HMW"/>
</coding>
<text value="SE-UHPLC HMW (%)"/>
</code>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="SE-UHPLCHMW-15"/>
<display value="SE-UHPLC HMW - 15"/>
</coding>
</code>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="SE-UHPLCHMW-25"/>
<display value="SE-UHPLC HMW - 25"/>
</coding>
</code>
</component>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e8"/>
<resource>
<ObservationDefinition>
<!-- CEX-HPLCAcidicPeak -->
<id value="54bb47fd-8964-4f96-6495-b2bec7f161e8"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="54bb47fd-8964-4f96-6495-b2bec7f161e8"> </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 "54bb47fd-8964-4f96-6495-b2bec7f161e8" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/54bb47fd-8964-4f96-6495-b2bec7f161e8</code></p><p><b>title</b>: CEX-HPLC % Acidic Peak</p><p><b>status</b>: active</p><p><b>code</b>: CEX-HPLC Acidic 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>#CEX-HPLCAcidicPeak "CEX-HPLC Acidic Peak")</span></p><blockquote><p><b>component</b></p><p><b>code</b>: CEX-HPLC Acidic Peak - 15 <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>#CEX-HPLCAcidicPeak-15)</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: CEX-HPLC Acidic Peak - 25 <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>#CEX-HPLCAcidicPeak-25)</span></p></blockquote></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958424 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/54bb47fd-8964-4f96-6495-b2bec7f161e8"/>
<title value="CEX-HPLC % Acidic Peak"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="CEX-HPLCAcidicPeak"/>
<display value="CEX-HPLC Acidic Peak"/>
</coding>
<text value="CEX-HPLC Acidic Peak (%)"/>
</code>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="CEX-HPLCAcidicPeak-15"/>
<display value="CEX-HPLC Acidic Peak - 15"/>
</coding>
</code>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="CEX-HPLCAcidicPeak-25"/>
<display value="CEX-HPLC Acidic Peak - 25"/>
</coding>
</code>
</component>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:74525a3d-5034-448a-9c19-938ce1958424"/>
<resource>
<ObservationDefinition>
<!-- CEX-HPLCMainPeak -->
<id value="74525a3d-5034-448a-9c19-938ce1958424"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="74525a3d-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 "74525a3d-5034-448a-9c19-938ce1958424" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958424</code></p><p><b>title</b>: CEX-HPLC % Main Peak</p><p><b>status</b>: active</p><p><b>code</b>: CEX-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>#CEX-HPLCMainPeak "CEX-HPLC Main Peak")</span></p><blockquote><p><b>component</b></p><p><b>code</b>: CEX-HPLC Main Peak - 15 <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>#CEX-HPLCMainPeak-15)</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: CEX-HPLC Main Peak - 25 <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>#CEX-HPLCMainPeak-25)</span></p></blockquote></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958424 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958424"/>
<title value="CEX-HPLC % Main Peak"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="CEX-HPLCMainPeak"/>
<display value="CEX-HPLC Main Peak"/>
</coding>
<text value="CEX-HPLC Main Peak (%)"/>
</code>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="CEX-HPLCMainPeak-15"/>
<display value="CEX-HPLC Main Peak - 15"/>
</coding>
</code>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="CEX-HPLCMainPeak-25"/>
<display value="CEX-HPLC Main Peak - 25"/>
</coding>
</code>
</component>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:44ba47fd-8964-4f96-6495-b2bec7f161e7"/>
<resource>
<Observation>
<!-- SE-UHPLCMainPeak1 -->
<id value="44ba47fd-8964-4f96-6495-b2bec7f161e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="44ba47fd-8964-4f96-6495-b2bec7f161e7"> </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 "44ba47fd-8964-4f96-6495-b2bec7f161e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_64525a3d-5034-448a-9c19-938ce1958424">See above (ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: SE-UHPLC 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>#SE-UHPLCMainPeak "SE-UHPLC Main Peak")</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>: SE-UHPLC Main Peak - 15 <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>#SE-UHPLCMainPeak-15)</span></p><p><b>value</b>: 8.5 %</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: SE-UHPLC Main Peak - 25 <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>#SE-UHPLCMainPeak-25)</span></p><p><b>value</b>: 9.5 %</p></blockquote></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/SE-UHPLCMainPeak -->
<reference
value="ObservationDefinition/64525a3d-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="SE-UHPLCMainPeak"/>
<display value="SE-UHPLC Main Peak"/>
</coding>
<text value="SE-UHPLC Main Peak (%)"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-1 -->
<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="SE-UHPLCMainPeak-15"/>
<display value="SE-UHPLC Main Peak - 15"/>
</coding>
</code>
<valueQuantity>
<value value="8.5"/>
<unit value="%"/>
</valueQuantity>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="SE-UHPLCMainPeak-25"/>
<display value="SE-UHPLC Main Peak - 25"/>
</coding>
</code>
<valueQuantity>
<value value="9.5"/>
<unit value="%"/>
</valueQuantity>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:54ca47fd-8964-4f96-6495-b2bec7f162e7"/>
<resource>
<Observation>
<!-- SE-UHPLCMainPeak2 -->
<id value="54ca47fd-8964-4f96-6495-b2bec7f162e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="54ca47fd-8964-4f96-6495-b2bec7f162e7"> </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 "54ca47fd-8964-4f96-6495-b2bec7f162e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_64525a3d-5034-448a-9c19-938ce1958424">See above (ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: SE-UHPLC 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>#SE-UHPLCMainPeak "SE-UHPLC Main Peak")</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><blockquote><p><b>component</b></p><p><b>code</b>: SE-UHPLC Main Peak - 15 <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>#SE-UHPLCMainPeak-15)</span></p><p><b>value</b>: 12.5 %</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: SE-UHPLC Main Peak - 25 <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>#SE-UHPLCMainPeak-25)</span></p><p><b>value</b>: 13.5 %</p></blockquote></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/SE-UHPLCMainPeak -->
<reference
value="ObservationDefinition/64525a3d-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="SE-UHPLCMainPeak"/>
<display value="SE-UHPLC Main Peak"/>
</coding>
<text value="SE-UHPLC Main Peak (%)"/>
</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>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="SE-UHPLCMainPeak-15"/>
<display value="SE-UHPLC Main Peak - 15"/>
</coding>
</code>
<valueQuantity>
<value value="12.5"/>
<unit value="%"/>
</valueQuantity>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="SE-UHPLCMainPeak-25"/>
<display value="SE-UHPLC Main Peak - 25"/>
</coding>
</code>
<valueQuantity>
<value value="13.5"/>
<unit value="%"/>
</valueQuantity>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:44ba47fd-8964-4f97-6495-b2bec7f161e7"/>
<resource>
<Observation>
<!-- SE-UHPLCHMW1 -->
<id value="44ba47fd-8964-4f97-6495-b2bec7f161e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="44ba47fd-8964-4f97-6495-b2bec7f161e7"> </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 "44ba47fd-8964-4f97-6495-b2bec7f161e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_64525a33-5034-448a-9c19-938ce1958424">See above (ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: SE-UHPLC HMW (%) <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>#SE-UHPLCHMW "SE-UHPLC HMW")</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>: SE-UHPLC HMW - 15 <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>#SE-UHPLCHMW-15)</span></p><p><b>value</b>: 73.0 %</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: SE-UHPLC HMW - 25 <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>#SE-UHPLCHMW-25)</span></p><p><b>value</b>: 79.0 %</p></blockquote></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/SE-UHPLCHMW -->
<reference
value="ObservationDefinition/64525a33-5034-448a-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="SE-UHPLCHMW"/>
<display value="SE-UHPLC HMW"/>
</coding>
<text value="SE-UHPLC HMW (%)"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-1 -->
<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="SE-UHPLCHMW-15"/>
<display value="SE-UHPLC HMW - 15"/>
</coding>
</code>
<valueQuantity>
<value value="73.0"/>
<unit value="%"/>
</valueQuantity>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="SE-UHPLCHMW-25"/>
<display value="SE-UHPLC HMW - 25"/>
</coding>
</code>
<valueQuantity>
<value value="79.0"/>
<unit value="%"/>
</valueQuantity>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:54ca47fd-8964-4f98-6495-b2bec7f162e7"/>
<resource>
<Observation>
<!-- SE-UHPLCHMW2 -->
<id value="54ca47fd-8964-4f98-6495-b2bec7f162e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="54ca47fd-8964-4f98-6495-b2bec7f162e7"> </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 "54ca47fd-8964-4f98-6495-b2bec7f162e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_64525a33-5034-448a-9c19-938ce1958424">See above (ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: SE-UHPLC HMW (%) <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>#SE-UHPLCHMW "SE-UHPLC HMW")</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><blockquote><p><b>component</b></p><p><b>code</b>: SE-UHPLC HMW - 15 <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>#SE-UHPLCHMW-15)</span></p><p><b>value</b>: 74.0 %</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: SE-UHPLC HMW - 25 <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>#SE-UHPLCHMW-25)</span></p><p><b>value</b>: 78.0 %</p></blockquote></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/SE-UHPLCHMW -->
<reference
value="ObservationDefinition/64525a33-5034-448a-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="SE-UHPLCHMW"/>
<display value="SE-UHPLC HMW"/>
</coding>
<text value="SE-UHPLC HMW (%)"/>
</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>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="SE-UHPLCHMW-15"/>
<display value="SE-UHPLC HMW - 15"/>
</coding>
</code>
<valueQuantity>
<value value="74.0"/>
<unit value="%"/>
</valueQuantity>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="SE-UHPLCHMW-25"/>
<display value="SE-UHPLC HMW - 25"/>
</coding>
</code>
<valueQuantity>
<value value="78.0"/>
<unit value="%"/>
</valueQuantity>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e7"/>
<resource>
<Observation>
<!-- CEX-HPLC-1 -->
<id value="54ba47fd-8964-4f96-6495-b2bec7f161e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="54ba47fd-8964-4f96-6495-b2bec7f161e7"> </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 "54ba47fd-8964-4f96-6495-b2bec7f161e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_74525a3d-5034-448a-9c19-938ce1958424">See above (ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: CEX-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>#CEX-HPLCMainPeak "CEX-HPLC Main Peak")</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>: CEX-HPLC Main Peak - 15 <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>#CEX-HPLCMainPeak-15)</span></p><p><b>value</b>: 18.5 %</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: CEX-HPLC Main Peak - 25 <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>#CEX-HPLCMainPeak-25)</span></p><p><b>value</b>: 19.5 %</p></blockquote></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/CEX-HPLCMainPeak -->
<reference
value="ObservationDefinition/74525a3d-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="CEX-HPLCMainPeak"/>
<display value="CEX-HPLC Main Peak"/>
</coding>
<text value="CEX-HPLC Main Peak (%)"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-1 -->
<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="CEX-HPLCMainPeak-15"/>
<display value="CEX-HPLC Main Peak - 15"/>
</coding>
</code>
<valueQuantity>
<value value="18.5"/>
<unit value="%"/>
</valueQuantity>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="CEX-HPLCMainPeak-25"/>
<display value="CEX-HPLC Main Peak - 25"/>
</coding>
</code>
<valueQuantity>
<value value="19.5"/>
<unit value="%"/>
</valueQuantity>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:54bb47fd-8964-4f96-6495-b2bec7f161e7"/>
<resource>
<Observation>
<!-- CEX-HPLC-2 -->
<id value="54bb47fd-8964-4f96-6495-b2bec7f161e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="54bb47fd-8964-4f96-6495-b2bec7f161e7"> </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 "54bb47fd-8964-4f96-6495-b2bec7f161e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_74525a3d-5034-448a-9c19-938ce1958424">See above (ObservationDefinition/74525a3d-5034-448a-9c19-938ce1958424)</a></p><p><b>status</b>: final</p><p><b>code</b>: CEX-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>#CEX-HPLCMainPeak "CEX-HPLC Main Peak")</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><blockquote><p><b>component</b></p><p><b>code</b>: CEX-HPLC Main Peak - 15 <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>#CEX-HPLCMainPeak-15)</span></p><p><b>value</b>: 15.5 %</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: CEX-HPLC Main Peak - 25 <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>#CEX-HPLCMainPeak-25)</span></p><p><b>value</b>: 16.5 %</p></blockquote></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/CEX-HPLCMainPeak -->
<reference
value="ObservationDefinition/74525a3d-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="CEX-HPLCMainPeak"/>
<display value="CEX-HPLC Main Peak"/>
</coding>
<text value="CEX-HPLC Main Peak (%)"/>
</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>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="CEX-HPLCMainPeak-15"/>
<display value="CEX-HPLC Main Peak - 15"/>
</coding>
</code>
<valueQuantity>
<value value="15.5"/>
<unit value="%"/>
</valueQuantity>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="CEX-HPLCMainPeak-25"/>
<display value="CEX-HPLC Main Peak - 25"/>
</coding>
</code>
<valueQuantity>
<value value="16.5"/>
<unit value="%"/>
</valueQuantity>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:54ba47fd-8964-4f96-6495-b2bec7f161e8"/>
<resource>
<Observation>
<!-- CEX-Acidic-1 -->
<id value="54ba47fd-8964-4f96-6495-b2bec7f161e8"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="54ba47fd-8964-4f96-6495-b2bec7f161e8"> </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 "54ba47fd-8964-4f96-6495-b2bec7f161e8" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_54bb47fd-8964-4f96-6495-b2bec7f161e8">See above (ObservationDefinition/54bb47fd-8964-4f96-6495-b2bec7f161e8)</a></p><p><b>status</b>: final</p><p><b>code</b>: CEX-HPLC Acidic 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>#CEX-HPLCAcidicPeak "CEX-HPLC Acidic Peak")</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>: CEX-HPLC Acidic 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>#CEX-HPLCAcidicPeak-15 "CEX-HPLC Acidic Peak - 15")</span></p><p><b>value</b>: 28.5 %</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: CEX-HPLC Acidic 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>#CEX-HPLCAcidicPeak-25 "CEX-HPLC Acidic Peak - 25")</span></p><p><b>value</b>: 29.5 %</p></blockquote></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/CEX-HPLCAcidicPeak -->
<reference
value="ObservationDefinition/54bb47fd-8964-4f96-6495-b2bec7f161e8"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="CEX-HPLCAcidicPeak"/>
<display value="CEX-HPLC Acidic Peak"/>
</coding>
<text value="CEX-HPLC Acidic Peak (%)"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-1 -->
<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="CEX-HPLCAcidicPeak-15"/>
<display value="CEX-HPLC Acidic Peak - 15"/>
</coding>
<text value="CEX-HPLC Acidic Peak (%)"/>
</code>
<valueQuantity>
<value value="28.5"/>
<unit value="%"/>
</valueQuantity>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="CEX-HPLCAcidicPeak-25"/>
<display value="CEX-HPLC Acidic Peak - 25"/>
</coding>
<text value="CEX-HPLC Acidic Peak (%)"/>
</code>
<valueQuantity>
<value value="29.5"/>
<unit value="%"/>
</valueQuantity>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:54ba48fd-8964-4f96-6495-b2bec7f161e7"/>
<resource>
<Observation>
<!-- CEX-Acidic-2 -->
<id value="54ba48fd-8964-4f96-6495-b2bec7f161e7"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="54ba48fd-8964-4f96-6495-b2bec7f161e7"> </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 "54ba48fd-8964-4f96-6495-b2bec7f161e7" </p></div><p><b>instantiates</b>: <a href="#ObservationDefinition_54bb47fd-8964-4f96-6495-b2bec7f161e8">See above (ObservationDefinition/54bb47fd-8964-4f96-6495-b2bec7f161e8)</a></p><p><b>status</b>: final</p><p><b>code</b>: CEX-HPLC Acidic 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>#CEX-HPLCAcidicPeak "CEX-HPLC Acidic Peak")</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>: CEX-HPLC Acidic 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>#CEX-HPLCAcidicPeak-15 "CEX-HPLC Acidic Peak - 15")</span></p><p><b>value</b>: 28.6 %</p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: CEX-HPLC Acidic 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>#CEX-HPLCAcidicPeak-25 "CEX-HPLC Acidic Peak - 25")</span></p><p><b>value</b>: 29.3 %</p></blockquote></div>
</text>
<instantiatesReference>
<!-- ObservationDefinition/CEX-HPLCAcidicPeak -->
<reference
value="ObservationDefinition/54bb47fd-8964-4f96-6495-b2bec7f161e8"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="CEX-HPLCAcidicPeak"/>
<display value="CEX-HPLC Acidic Peak"/>
</coding>
<text value="CEX-HPLC Acidic Peak (%)"/>
</code>
<subject>
<!-- Medication/medication-actual-batch-1 -->
<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="CEX-HPLCAcidicPeak-15"/>
<display value="CEX-HPLC Acidic Peak - 15"/>
</coding>
<text value="CEX-HPLC Acidic Peak (%)"/>
</code>
<valueQuantity>
<value value="28.6"/>
<unit value="%"/>
</valueQuantity>
</component>
<component>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="CEX-HPLCAcidicPeak-25"/>
<display value="CEX-HPLC Acidic Peak - 25"/>
</coding>
<text value="CEX-HPLC Acidic Peak (%)"/>
</code>
<valueQuantity>
<value value="29.3"/>
<unit value="%"/>
</valueQuantity>
</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-dxpq-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><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ProductName</b></td></tr><tr><td style="display: none">*</td><td>Stelbatolol</td></tr></table></div>
</text>
<description value="Textual description of the product"/>
<name>
<productName value="Stelbatolol"/>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
<resource>
<Medication>
<!-- medication-actual-batch-1 -->
<id value="339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
<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></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>88877</td></tr></table></div>
</text>
<!-- contained>
<PackagedProductDefinition>
<id value="ppd1-nosubject"/>
<packaging>
<type>
<coding>
<system value="http://hl7.org/fhir/packaging-type"/>
<code value="100000073544"/>
<display value="Pre-filled syringe"/>
</coding>
</type>
</packaging>
</PackagedProductDefinition>
</contained -->
<!-- can use an extension here to point to package, but currently just relying on medication-manufacturingBatch to have a text description -->
<code>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq">
<valueReference>
<!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1 -->
<reference
value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
</valueReference>
</extension>
</code>
<batch>
<extension
url="http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch">
<extension url="container">
<extension url="closureSystemDescription">
<valueString value="Pre-filled syringe"/>
</extension>
</extension>
</extension>
<lotNumber value="88877"/>
</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>88878</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-dxpq-ex1 -->
<reference
value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
</valueReference>
</extension>
</code>
<batch>
<extension
url="http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch">
<extension url="container">
<extension url="closureSystemDescription">
<valueString value="Autoinjector Pen"/>
</extension>
</extension>
</extension>
<lotNumber value="88878"/>
</batch>
</Medication>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08"/>
<resource>
<Organization>
<!-- 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>
</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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