Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

: Process 1.0

Active as of 2026-05-10

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@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:l <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:l <http://terminology.hl7.org/CodeSystem/v3-ObservationValue>       ] ;
fhir:code [ fhir:v "SUBSETTED" ]     ] )
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n  <table class=\"narrative-table\">\n    <tbody>\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">Metadata</th>\n\n\n</tr>\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Process 1.0</td>\n\n\n</tr>\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Version</th>\n\n\n\n<td class=\"content-container\">1.0.0</td>\n\n\n</tr>\n\n\n\n\n\n\n\n  \n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Identifier</th>\n\n\n\n<td class=\"content-container\">urn:oid:2.16.840.1.113883.4.642.40.41.34.2</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Subject Type</th>\n\n\n\n<td class=\"content-container\"><a href=\"MedicinalProductDefinition-medicinalproductdefinition-drug-product-pq-ex1.html\">MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use</a></td>\n\n\n</tr>\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Jurisdiction</th>\n\n\n\n<td class=\"content-container\">\n    World\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Steward (Publisher)</th>\n\n\n\n<td class=\"content-container\">HL7 International / Biomedical Research and Regulation</td>\n\n\n</tr>\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Steward Contact</th>\n\n\n\n<td class=\"content-container\">HL7 International / Biomedical Research and Regulation</td>\n\n\n</tr>\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Description</th>\n\n\n\n<td class=\"content-container\"><div><p>Narrative description of manufacturing process (5)</p>\n</div></td>\n\n\n</tr>\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Type</th>\n\n\n\n<td class=\"content-container\">\n    Workflow Definition\n\n\n    Manufacturing Process\n\n\n</td>\n\n\n</tr>\n\n\n\n\n\n\n<tr>\n  <th colspan=\"2\" scope=\"row\" class=\"row-header\">Generated using version 0.5.4 of the sample-content-ig Liquid templates</th>\n</tr>\n\n    </tbody>\n  </table>\n</div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:extension ( [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq>     ] ;
fhir:value [
a fhir:Markdown ;
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:l <http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan>
  ] ; # 
  fhir:identifier ( [
fhir:system [
fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ;
fhir:l <urn:ietf:rfc:3986>     ] ;
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:l <http://terminology.hl7.org/CodeSystem/plan-definition-type>       ] ;
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:l <http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type>       ] ;
fhir:code [ fhir:v "manufacturing-process" ] ;
fhir:display [ fhir:v "Manufacturing Process" ]     ] )
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:subject [
a fhir:Reference ;
fhir:l fhir:MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1 ;
fhir:reference [ fhir:v "MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1" ]
  ] ; # 
  fhir:date [ fhir:v "2026-05-10T20:32:51+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:l <http://unstats.un.org/unsd/methods/m49/m49.htm>       ] ;
fhir:code [ fhir:v "001" ] ;
fhir:display [ 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:l <http://terminology.hl7.org/CodeSystem/pharmaceutical-test-category>         ] ;
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:l <http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-pq-example>         ] ;
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:l <http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example>           ] ;
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 ] ;
fhir:unit [ fhir:v "pH" ]         ] ;
fhir:high [
fhir:value [ fhir:v 7.1 ] ;
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:l <http://terminology.hl7.org/CodeSystem/pharmaceutical-test-category>         ] ;
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:l <http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-pq-example>         ] ;
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:l <http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example>           ] ;
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:l <http://terminology.hl7.org/CodeSystem/pharmaceutical-test-category>         ] ;
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:l <http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-pq-example>         ] ;
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:l <http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example>           ] ;
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" ]         ]       ]     ] )
  ] ) . #