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
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- # Product Analytical Procedure a fhir:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "bundle-analytical-procedure-pq-ex1-prod"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq> ] ) ] ; # fhir:type [ fhir:v "collection"] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f81"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f81> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5> ) ] ) . # <urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f> a fhir:PlanDefinition ; fhir:id [ fhir:v "analyticalProcedure"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"analyticalProcedure\"> </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-cs-planType-local-pq.html\">CodeSystem - Plan Type</a>#analytical-procedure "Analytical Procedure")</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><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-cs-manufacturingParticipantRole-local-pq.html\">CodeSystem - Manufacturing Participant Role</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-cs-manufacturingParticipantRole-local-pq.html\">CodeSystem - Manufacturing Participant Role</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>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f"^^xsd:anyURI] ; # http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f fhir:title [ fhir:v "Analytical Procedure"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/plan-definition-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "workflow-definition" ] ; fhir:display [ fhir:v "Workflow Definition" ] ] [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-planType-local-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "analytical-procedure" ] ; fhir:display [ fhir:v "Analytical Procedure" ] ] ) ] ; # fhir:status [ fhir:v "active"] ; # fhir:subject [ a fhir:Reference ; fhir:reference [ fhir:v "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" ] # MedicinalProductDefinition\/medicinalproductdefinition-drug-product-dxpq-ex1 ] ; # fhir:action ( [ fhir:title [ fhir:v "Preparation and Analysis of Drug Product Samples" ] ; ( fhir:participant [ fhir:typeReference [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8035565f81" ] # SubstanceDefinition\/diluent ] ] ) ; fhir:display [ fhir:v "Diluent" ] ] ; fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "diluent" ] ; fhir:display [ fhir:v "Diluent" ] ] ) ] ] [ fhir:typeReference [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8035565f82" ] # SubstanceDefinition\/resultingMaterial ] ] ) ; fhir:display [ fhir:v "Resulting material" ] ] ; fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "ResultingMaterial" ] ; fhir:display [ fhir:v "Resulting Material" ] ] ) ] ] ) ; ( fhir:action [ fhir:title [ fhir:v "Sample Preparation" ] ; ( fhir:action [ fhir:title [ fhir:v "Instructions" ] ; fhir:description [ fhir:v "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." ] ] ) ] [ fhir:title [ fhir:v "Sample Analysis" ] ; ( fhir:action [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e"^^xsd:anyURI ] # ObservationDefinition\/SampleAnalysis ] ) ] ) ] ) . # <urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f81> a fhir:SubstanceDefinition ; fhir:id [ fhir:v "9f69ec9c-5fd1-30d2-0790-9e8035565f81"] ; # diluent fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"9f69ec9c-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>" ] ; # fhir:name ( [ fhir:name [ fhir:v "0.05 % trifluoroacetic acid (TFA) in 50:50 acetonitrile: water (v/v)" ] ] ) . # <urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82> a fhir:SubstanceDefinition ; fhir:id [ fhir:v "9f69ec9c-5fd1-30d2-0790-9e8035565f82"] ; # resultingMaterial fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"9f69ec9c-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>" ] ; # fhir:name ( [ fhir:name [ fhir:v "Stelbat in Diluent (approximately 0.36 mg/mL)" ] ] ) . # <urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e> a fhir:ObservationDefinition ; fhir:id [ fhir:v "12e7e672-40a6-4136-3c1f-b8ba6a7d046e"] ; # SampleAnalysis fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-40a6-4136-3c1f-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>: <a href=\"#SpecimenDefinition_3a0cde98-4a73-6d67-1dfc-08e3fc9646a2\">See above (SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2)</a></p><p><b>hasMember</b>: </p><ul><li><a href=\"#ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d045e\">See above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e)</a></li><li><a href=\"#ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d046e\">See above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e)</a></li></ul></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e"^^xsd:anyURI] ; # http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e fhir:title [ fhir:v "Sample Analysis"] ; # fhir:status [ fhir:v "active"] ; # fhir:description [ fhir:v "Number of Injections: 1 of each preparation"] ; # fhir:code [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/data-absent-reason"^^xsd:anyURI ] ; fhir:value [ fhir:v "unsupported" ] ] ) ] ; # fhir:specimen ( [ fhir:reference [ fhir:v "SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2" ] # SpecimenDefinition\/specimendefinition ] ) ; # fhir:hasMember ( [ fhir:reference [ fhir:v "ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e" ] # ObservationDefinition\/Assay ] [ fhir:reference [ fhir:v "ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e" ] # ObservationDefinition\/Identity ] ) . # <urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e> a fhir:ObservationDefinition ; fhir:id [ fhir:v "12e7e672-40a6-4036-3c1f-b8ba6a7d045e"] ; # Assay fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n <div style=\"font-family: 'Times New Roman', Times, serif;\">\n <p>Determine the amount of Stelbat in each sample replicate as follows:</p>\n <p>\n \n <!-- <img alt=\"formula\" width=\"203\" height=\"34\" style=\"display: block; margin-left: auto; margin-right: auto;\" src=\"#imageResource\"/> -->\n </p>\n <p>\n <span>Where:</span>\n </p>\n <p>\n <span>A\n <sub>SPL</sub> = Area of Stelbat in the sample \n </span>\n </p>\n <p>\n <span>ANSR = Average normalized standard response factor of standard injections</span>\n </p>\n <p>\n <span>DF = Overall sample dilution factor</span>\n </p>\n <p>\n <span>N = Number of tablets in sample preparation</span>\n </p>\n <p>\n <span>Determine the % label claim of the sample as follows:</span>\n </p>\n <p>\n \n <!-- <img alt=\"formula\" width=\"220\" height=\"34\" style=\"display: block; margin-left: auto; margin-right: auto;\" src=\"#imageResource2\"/> -->\n </p>\n <p>\n <span>Where:</span>\n </p>\n <p>\n <span>LC = Label claim (mg/tablet) of tested sample</span>\n </p>\n </div>\n </div>" ] ; # fhir:contained ( [ a fhir:Binary ; fhir:id [ fhir:v "imageResource" ] ; fhir:contentType [ fhir:v "image/png" ] ; # example format fhir:data [ fhir:v 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"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"^^xsd:base64Binary ] # data is base 64 encoded, actual bytes of the image png file ] ) ; # fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"^^xsd:anyURI] ; # http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e fhir:title [ fhir:v "Assay (w/w%)"] ; # fhir:status [ fhir:v "active"] ; # fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "ASSAY" ] ; fhir:display [ fhir:v "Assay" ] ] ) ; fhir:text [ fhir:v "Assay (w/w%)" ] ] ; # fhir:qualifiedValue ( [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq"^^xsd:anyURI ] ; fhir:value [ fhir:v "The %RSD between the two assay results must be ≤ 1.5%" ] ] ) ] ) . # <urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e> a fhir:ObservationDefinition ; fhir:id [ fhir:v "12e7e672-40a6-4036-3c1f-b8ba6a7d046e"] ; # Identity fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-40a6-4036-3c1f-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.html\">CodeSystem - 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>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e"^^xsd:anyURI] ; # http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e fhir:title [ fhir:v "Identity"] ; # fhir:status [ fhir:v "active"] ; # fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "IDT" ] ; fhir:display [ fhir:v "Identification" ] ] ) ; fhir:text [ fhir:v "Identity" ] ] ; # fhir:qualifiedValue ( [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq"^^xsd:anyURI ] ; fhir:value [ fhir:v "1. The retention time ratio of the sample peak to standard peak is within 0.95 to 1.05." ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq"^^xsd:anyURI ] ; fhir:value [ fhir:v "2. The UV spectrum of the sample peak compares favorably to the UV spectrum of the standard peak from 210 nm to 400 nm." ] ] ) ] ) . # <urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2> a fhir:SpecimenDefinition ; fhir:id [ fhir:v "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"] ; # specimendefinition fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SpecimenDefinition</b><a name=\"3a0cde98-4a73-6d67-1dfc-08e3fc9646a2\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SpecimenDefinition "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2" </p></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>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"^^xsd:anyURI] ; # http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2 fhir:status [ fhir:v "active"] ; # fhir:description [ fhir:v "Number of Preparations: 2 (only 1 is required for identity)"] ; # fhir:typeTested ( [ fhir:preference [ fhir:v "preferred" ] ; ( fhir:handling [ fhir:maxDuration [ fhir:value [ fhir:v "4"^^xsd:decimal ] ; fhir:unit [ fhir:v "days" ] ] ; fhir:instruction [ fhir:v "at ambient or refrigerated conditions protected from light (may be extended with supporting data)" ] ] ) ] ) . # <urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"] ; # medicinalproductdefinition-drug-product-dxpq-ex1 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<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>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>" ] ; # fhir:combinedPharmaceuticalDoseForm [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ; fhir:code [ fhir:v "10225000" ] ; fhir:display [ fhir:v "Gastro-resistant tablet" ] ] ) ] ; # fhir:route ( [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ; fhir:code [ fhir:v "20053000" ] ; fhir:display [ fhir:v "Oral use" ] ] ) ] ) ; # fhir:name ( [ fhir:productName [ fhir:v "Stelbat Tablets, 20mg" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-local-pq"^^xsd:anyURI ] ; fhir:code [ fhir:v "Proprietary" ] ; fhir:display [ fhir:v "Proprietary" ] ] ) ] ; ( fhir:part [ fhir:part [ fhir:v "20mg" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-name-part-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "StrengthPart" ] ; fhir:display [ fhir:v "Strength part" ] ] ) ] ] ) ] ) . #
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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