Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry)
1.0.0 - STU1
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions
<!-- Product Analytical Procedure -->
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundle-analytical-procedure-pq-ex1-prod"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq"/>
</meta>
<type value="collection"/>
<entry>
<fullUrl value="urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f"/>
<resource>
<PlanDefinition>
<id value="analyticalProcedure"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PlanDefinition_analyticalProcedure"> </a><p><b>Generated Narrative: PlanDefinition</b><a name="analyticalProcedure"> </a><a name="hcanalyticalProcedure"> </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 "analyticalProcedure" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f</code></p><p><b>title</b>: Analytical Procedure</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-pharmaceutical-plan-type.html">Pharmaceutical Plan Type Codes</a>#analytical-procedure "Analytical Procedure")</span></p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5</p><blockquote><p><b>action</b></p><p><b>title</b>: Preparation and Analysis of Drug Product Samples</p><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: Diluent</span></p><p><b>role</b>: Diluent <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-participant-role.html">Manufacturing Participant Role Codes</a>#diluent)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: Resulting material</span></p><p><b>role</b>: Resulting Material <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-participant-role.html">Manufacturing Participant Role Codes</a>#ResultingMaterial)</span></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Preparation</p><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Analysis</p><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="Analytical Procedure"/>
<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://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type"/>
<code value="analytical-procedure"/>
<display value="Analytical Procedure"/>
</coding>
</type>
<status value="active"/>
<subjectReference>
<!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1 -->
<reference
value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
</subjectReference>
<action>
<title value="Preparation and Analysis of Drug Product Samples"/>
<participant>
<typeReference>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq">
<valueReference>
<!-- SubstanceDefinition/diluent -->
<reference
value="SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8035565f81"/>
</valueReference>
</extension>
<display value="Diluent"/>
</typeReference>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-participant-role"/>
<code value="diluent"/>
<display value="Diluent"/>
</coding>
</role>
</participant>
<participant>
<typeReference>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq">
<valueReference>
<!-- SubstanceDefinition/resultingMaterial -->
<reference
value="SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8035565f82"/>
</valueReference>
</extension>
<display value="Resulting material"/>
</typeReference>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/manufacturing-participant-role"/>
<code value="ResultingMaterial"/>
<display value="Resulting Material"/>
</coding>
</role>
</participant>
<action>
<title value="Sample Preparation"/>
<action>
<title value="Instructions"/>
<description
value="Transfer 5 tablets into a volumetric flask. Add a portion of the diluent and shake on mechanical shaker until tablets are completely disintegrated. Dilute to volume with diluent. Do not exceed 2 mg/mL in the initial dilution. Filter or centrifuge."/>
</action>
</action>
<action>
<title value="Sample Analysis"/>
<action>
<code>
<text value="Test"/>
</code>
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e"/>
</action>
</action>
</action>
</PlanDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f81"/>
<resource>
<SubstanceDefinition>
<!-- diluent -->
<id value="9f69ec9c-5fd1-30d2-0790-9e8035565f81"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_9f69ec9c-5fd1-30d2-0790-9e8035565f81"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="9f69ec9c-5fd1-30d2-0790-9e8035565f81"> </a><a name="hc9f69ec9c-5fd1-30d2-0790-9e8035565f81"> </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 "9f69ec9c-5fd1-30d2-0790-9e8035565f81" </p></div><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>0.05 % trifluoroacetic acid (TFA) in 50:50 acetonitrile: water (v/v)</td></tr></table></div>
</text>
<name>
<name
value="0.05 % trifluoroacetic acid (TFA) in 50:50 acetonitrile: water (v/v)"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82"/>
<resource>
<SubstanceDefinition>
<!-- resultingMaterial -->
<id value="9f69ec9c-5fd1-30d2-0790-9e8035565f82"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_9f69ec9c-5fd1-30d2-0790-9e8035565f82"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="9f69ec9c-5fd1-30d2-0790-9e8035565f82"> </a><a name="hc9f69ec9c-5fd1-30d2-0790-9e8035565f82"> </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 "9f69ec9c-5fd1-30d2-0790-9e8035565f82" </p></div><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>Stelbat in Diluent (approximately 0.36 mg/mL)</td></tr></table></div>
</text>
<name>
<name value="Stelbat in Diluent (approximately 0.36 mg/mL)"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e"/>
<resource>
<ObservationDefinition>
<!-- SampleAnalysis -->
<id value="12e7e672-40a6-4136-3c1f-b8ba6a7d046e"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_12e7e672-40a6-4136-3c1f-b8ba6a7d046e"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="12e7e672-40a6-4136-3c1f-b8ba6a7d046e"> </a><a name="hc12e7e672-40a6-4136-3c1f-b8ba6a7d046e"> </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 "12e7e672-40a6-4136-3c1f-b8ba6a7d046e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e</code></p><p><b>title</b>: Sample Analysis</p><p><b>status</b>: active</p><p><b>description</b>: Number of Injections: 1 of each preparation</p><p><b>code</b>: <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>specimen</b>: See on this page: SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2</p><p><b>hasMember</b>: </p><ul><li>See on this page: ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e</li><li>See on this page: ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e</li></ul></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e -->
<url
value="http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e"/>
<title value="Sample Analysis"/>
<status value="active"/>
<description value="Number of Injections: 1 of each preparation"/>
<code>
<extension
url="http://hl7.org/fhir/StructureDefinition/data-absent-reason">
<valueCode value="unsupported"/>
</extension>
</code>
<specimen>
<!-- SpecimenDefinition/specimendefinition -->
<reference
value="SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
</specimen>
<hasMember>
<!-- ObservationDefinition/Assay -->
<reference
value="ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
</hasMember>
<hasMember>
<!-- ObservationDefinition/Identity -->
<reference
value="ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e"/>
</hasMember>
</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="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<div style="font-family: 'Times New Roman', Times, serif;">
<p>Determine the amount of Stelbat in each sample replicate as follows:</p>
<p>
<!-- <img alt="formula" width="203" height="34" style="display: block; margin-left: auto; margin-right: auto;" src="#imageResource"/> -->
</p>
<p>
<span>Where:</span>
</p>
<p>
<span>A
<sub>SPL</sub> = Area of Stelbat in the sample
</span>
</p>
<p>
<span>ANSR = Average normalized standard response factor of standard injections</span>
</p>
<p>
<span>DF = Overall sample dilution factor</span>
</p>
<p>
<span>N = Number of tablets in sample preparation</span>
</p>
<p>
<span>Determine the % label claim of the sample as follows:</span>
</p>
<p>
<!-- <img alt="formula" width="220" height="34" style="display: block; margin-left: auto; margin-right: auto;" src="#imageResource2"/> -->
</p>
<p>
<span>Where:</span>
</p>
<p>
<span>LC = Label claim (mg/tablet) of tested sample</span>
</p>
</div>
</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 (w/w%)"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
<text value="Assay (w/w%)"/>
</code>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString
value="The %RSD between the two assay results must be ≤ 1.5%"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:12e7e672-40a6-4036-3c2f-b8ba6a7d046e"/>
<resource>
<Binary>
<id value="imageResource"/>
<!-- example format -->
<contentType value="image/png"/>
<!-- data is base 64 encoded, actual bytes of the image png file -->
<data
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</Binary>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:12e7e672-40a6-4036-3c3f-b8ba6a7d046e"/>
<resource>
<Binary>
<id value="imageResource2"/>
<!-- example format -->
<contentType value="image/png"/>
<!-- data is base 64 encoded, actual bytes of the image png file -->
<data
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</Binary>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e"/>
<resource>
<ObservationDefinition>
<!-- Identity -->
<id value="12e7e672-40a6-4036-3c1f-b8ba6a7d046e"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d046e"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="12e7e672-40a6-4036-3c1f-b8ba6a7d046e"> </a><a name="hc12e7e672-40a6-4036-3c1f-b8ba6a7d046e"> </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-b8ba6a7d046e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e</code></p><p><b>title</b>: Identity</p><p><b>status</b>: active</p><p><b>code</b>: Identity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#IDT "Identification")</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>, </td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e -->
<url
value="http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e"/>
<title value="Identity"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="IDT"/>
<display value="Identification"/>
</coding>
<text value="Identity"/>
</code>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString
value="1. The retention time ratio of the sample peak to standard peak is within 0.95 to 1.05."/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString
value="2. The UV spectrum of the sample peak compares favorably to the UV spectrum of the standard peak from 210 nm to 400 nm."/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
<resource>
<SpecimenDefinition>
<!-- specimendefinition -->
<id value="3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SpecimenDefinition_3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"> </a><p><b>Generated Narrative: SpecimenDefinition</b><a name="3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"> </a><a name="hc3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource SpecimenDefinition "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2</code></p><p><b>status</b>: active</p><p><b>description</b>: Number of Preparations: 2 (only 1 is required for identity)</p><blockquote><p><b>typeTested</b></p><p><b>preference</b>: preferred</p><blockquote><p><b>handling</b></p><h3>MaxDurations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Value</b></td><td><b>Unit</b></td></tr><tr><td style="display: none">*</td><td>4</td><td>days</td></tr></table><p><b>instruction</b>: at ambient or refrigerated conditions protected from light (may be extended with supporting data)</p></blockquote></blockquote></div>
</text>
<!-- http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2 -->
<url
value="http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
<status value="active"/>
<description
value="Number of Preparations: 2 (only 1 is required for identity)"/>
<typeTested>
<preference value="preferred"/>
<handling>
<maxDuration>
<value value="4"/>
<unit value="days"/>
</maxDuration>
<instruction
value="at ambient or refrigerated conditions protected from light (may be extended with supporting data)"/>
</handling>
</typeTested>
</SpecimenDefinition>
</resource>
</entry>
<!-- MedicinalProductDefinition - the main resource in any product scenario -->
<entry>
<fullUrl value="urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
<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"><a name="MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"> </a><p><b>Generated Narrative: MedicinalProductDefinition</b><a name="a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"> </a><a name="hca0694a7a-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>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-pq-example.html">Product Name Type - example</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>
<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-pq-example"/>
<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>
</Bundle>
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0. Generated 2024-05-08
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