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
Active as of 2023-12-18 |
@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 -------------------------------------------------------------------
a fhir:PlanDefinition ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "plandefinition-drug-pq-ex2-manufacturing-plan"] ; #
fhir:meta [
( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq> ] ) ;
( fhir:tag [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v3-ObservationValue"^^xsd:anyURI ] ;
fhir:code [ fhir:v "SUBSETTED" ] ] )
] ; #
fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"plandefinition-drug-pq-ex2-manufacturing-plan\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource PlanDefinition "plandefinition-drug-pq-ex2-manufacturing-plan" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-PlanDefinition-drug-pq.html\">PlanDefinition - Drug PQ</a></p><p style=\"margin-bottom: 0px\">Tag: <span title=\"{http://terminology.hl7.org/CodeSystem/v3-ObservationValue http://terminology.hl7.org/CodeSystem/v3-ObservationValue}\">http://terminology.hl7.org/CodeSystem/v3-ObservationValue</span></p></div><p><b>Extension - History of Process PQ</b>: This can be text about the history</p><p><b>StructureDefinition Work Group</b>: brr</p><p><b>url</b>: <code>http://hl7.org/fhir/uv/pharm-quality/PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan</code></p><p><b>version</b>: 1.0.0-ballot</p><p><b>title</b>: Process 1.0</p><p><b>type</b>: Workflow Definition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-plan-definition-type.html\">PlanDefinitionType</a>#workflow-definition; <a href=\"CodeSystem-cs-planType-local-pq.html\">CodeSystem - Plan Type</a>#manufacturing-process "Manufacturing Process")</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-medicinalproductdefinition-drug-product-pq-ex1.html\">MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1</a></p><p><b>date</b>: 2023-12-18 16:00:45+0000</p><p><b>publisher</b>: HL7 International / Biomedical Research and Regulation</p><p><b>contact</b>: HL7 International - Biomedical Research and Regulation: <a href=\"http://www.hl7.org/Special/committees/rcrim\">http://www.hl7.org/Special/committees/rcrim</a></p><p><b>description</b>: Narrative description of manufacturing process (5)</p><p><b>jurisdiction</b>: World <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (m49.htm#001)</span></p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-pH</blockquote><p><b>category</b>: Physical Property <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-testCategory-local-pq.html\">CodeSystem - Test Category</a>#C123456)</span></p><p><b>description</b>: Controls - pH <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>priority</b>: Critical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-goalPriority-local-pq.html\">CodeSystem - Goal Priority</a>#critical)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>pH must be in range 6.9 to 7.1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#pH "pH")</span></td><td>6.9-7.1 pH</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-water-content</blockquote><p><b>category</b>: Physical Property <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-testCategory-local-pq.html\">CodeSystem - Test Category</a>#C123456)</span></p><p><b>description</b>: Controls - Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>priority</b>: Critical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-goalPriority-local-pq.html\">CodeSystem - Goal Priority</a>#critical)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Under 2% <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent "Water content")</span></td><td>?-2</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-particle-size</blockquote><p><b>category</b>: Physical Property <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-testCategory-local-pq.html\">CodeSystem - Test Category</a>#C123456)</span></p><p><b>description</b>: Controls - Particle Size <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>priority</b>: Critical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-goalPriority-local-pq.html\">CodeSystem - Goal Priority</a>#critical)</span></p><h3>Targets</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Under 200 microns <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#particle-size "Particle Size")</span></td><td>?-200</td></tr></table></blockquote></div>"
] ; #
fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq"^^xsd:anyURI ] ;
fhir:value [ fhir:v "This can be text about the history" ]
] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ;
fhir:value [ fhir:v "brr" ]
] ) ; #
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan"^^xsd:anyURI] ; #
fhir:version [ fhir:v "1.0.0-ballot"] ; #
fhir:title [ fhir:v "Process 1.0"] ; #
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 "manufacturing-process" ] ;
fhir:display [ fhir:v "Manufacturing Process" ] ] )
] ; #
fhir:status [ fhir:v "active"] ; #
fhir:subject [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1" ]
] ; #
fhir:date [ fhir:v "2023-12-18T16:00:45+00:00"^^xsd:dateTime] ; #
fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; #
fhir:contact ( [
fhir:name [ fhir:v "HL7 International - Biomedical Research and Regulation" ] ;
( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ] ] )
] ) ; #
fhir:description [ fhir:v "Narrative description of manufacturing process (5)"] ; #
fhir:jurisdiction ( [
( fhir:coding [
fhir:system [ fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ] ;
fhir:code [ fhir:v "001" ] ;
fhir:display [ fhir:v "World" ] ] ) ;
fhir:text [ fhir:v "World" ]
] ) ; #
fhir:goal ( [
fhir:id [ fhir:v "goal-control-pH" ] ;
fhir:category [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C123456" ] ;
fhir:display [ fhir:v "Physical Property" ] ] ) ] ;
fhir:description [
fhir:text [ fhir:v "Controls - pH" ] ] ;
fhir:priority [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-local-pq"^^xsd:anyURI ] ;
fhir:code [ fhir:v "critical" ] ;
fhir:display [ fhir:v "Critical" ] ] ) ] ;
( fhir:target [
fhir:measure [
( 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 "pH" ] ;
fhir:display [ fhir:v "pH" ] ] ) ;
fhir:text [ fhir:v "pH must be in range 6.9 to 7.1" ] ] ;
fhir:detail [
a fhir:Range ;
fhir:low [
fhir:value [ fhir:v "6.9"^^xsd:decimal ] ;
fhir:unit [ fhir:v "pH" ] ] ;
fhir:high [
fhir:value [ fhir:v "7.1"^^xsd:decimal ] ;
fhir:unit [ fhir:v "pH" ] ] ] ] )
] [
fhir:id [ fhir:v "goal-control-water-content" ] ;
fhir:category [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C123456" ] ;
fhir:display [ fhir:v "Physical Property" ] ] ) ] ;
fhir:description [
fhir:text [ fhir:v "Controls - Water Content" ] ] ;
fhir:priority [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-local-pq"^^xsd:anyURI ] ;
fhir:code [ fhir:v "critical" ] ;
fhir:display [ fhir:v "Critical" ] ] ) ] ;
( fhir:target [
fhir:measure [
( 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 "WaterContent" ] ;
fhir:display [ fhir:v "Water content" ] ] ) ;
fhir:text [ fhir:v "Under 2%" ] ] ;
fhir:detail [
a fhir:Range ;
fhir:high [
fhir:value [ fhir:v "2"^^xsd:decimal ] ;
fhir:unit [ fhir:v "%" ] ] ] ] )
] [
fhir:id [ fhir:v "goal-control-particle-size" ] ;
fhir:category [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C123456" ] ;
fhir:display [ fhir:v "Physical Property" ] ] ) ] ;
fhir:description [
fhir:text [ fhir:v "Controls - Particle Size" ] ] ;
fhir:priority [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-local-pq"^^xsd:anyURI ] ;
fhir:code [ fhir:v "critical" ] ;
fhir:display [ fhir:v "Critical" ] ] ) ] ;
( fhir:target [
fhir:measure [
( 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 "particle-size" ] ;
fhir:display [ fhir:v "Particle Size" ] ] ) ;
fhir:text [ fhir:v "Under 200 microns" ] ] ;
fhir:detail [
a fhir:Range ;
fhir:high [
fhir:value [ fhir:v "200"^^xsd:decimal ] ;
fhir:unit [ fhir:v "microns" ] ] ] ] )
] ) . #
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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