Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

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

: PlanDefinition - Drug - example, manufacturing plan - TTL Representation

Active as of 2024-05-08

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@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><a name=\"hcplandefinition-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 &quot;plandefinition-drug-pq-ex2-manufacturing-plan&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-PlanDefinition-drug-pq.html\">PlanDefinition - Drug PQ</a></p><p style=\"margin-bottom: 0px\">Tag: <span title=\"{http://terminology.hl7.org/CodeSystem/v3-ObservationValue http://terminology.hl7.org/CodeSystem/v3-ObservationValue}\">http://terminology.hl7.org/CodeSystem/v3-ObservationValue</span></p></div><p><b>Extension - History of Process PQ</b>: This can be text about the history</p><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan</code></p><p><b>identifier</b>: URI/urn:oid:2.16.840.1.113883.4.642.40.41.34.2</p><p><b>version</b>: 1.0.0</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-pharmaceutical-plan-type.html\">Pharmaceutical Plan Type Codes</a>#manufacturing-process &quot;Manufacturing Process&quot;)</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>: 2024-05-08 13:55:35+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-pharmaceutical-test-category.html\">Pharmaceutical Test Category Codes</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-pq-example.html\">Goal Priority - example</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-example.html\">Example Local Codes - Drug</a>#pH &quot;pH&quot;)</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-pharmaceutical-test-category.html\">Pharmaceutical Test Category Codes</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-pq-example.html\">Goal Priority - example</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-example.html\">Example Local Codes - Drug</a>#WaterContent &quot;Water content&quot;)</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-pharmaceutical-test-category.html\">Pharmaceutical Test Category Codes</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-pq-example.html\">Goal Priority - example</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-example.html\">Example Local Codes - Drug</a>#particle-size &quot;Particle Size&quot;)</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://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan"^^xsd:anyURI] ; # 
  fhir:identifier ( [
fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.40.41.34.2" ]
  ] ) ; # 
  fhir:version [ fhir:v "1.0.0"] ; # 
  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://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type"^^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 "2024-05-08T13:55:35+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://terminology.hl7.org/CodeSystem/pharmaceutical-test-category"^^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-pq-example"^^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-example"^^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://terminology.hl7.org/CodeSystem/pharmaceutical-test-category"^^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-pq-example"^^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-example"^^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://terminology.hl7.org/CodeSystem/pharmaceutical-test-category"^^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-pq-example"^^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-example"^^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" ]         ]       ]     ] )
  ] ) . #