Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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: Specification Section Type Terminology - TTL Representation

Active as of 2024-12-12

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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:ValueSet ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "cmc-specification-types-vs"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet cmc-specification-types-vs</b></p><a name=\"cmc-specification-types-vs\"> </a><a name=\"hccmc-specification-types-vs\"> </a><a name=\"cmc-specification-types-vs-en-US\"> </a><ul><li>Include these codes as defined in <code>http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use</code><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>ich_3.2.p.5.1</td><td>Specification(s)</td></tr><tr><td>ich_3.2.s.4.1</td><td>Specification</td></tr><tr><td>ich_3.2.p.4</td><td>Control of Excipients</td></tr></table></li></ul></div>"
  ] ; # 
  fhir:extension ( [
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/us/pq-cmc-fda/ValueSet/cmc-specification-types-vs"^^xsd:anyURI] ; # 
  fhir:identifier ( [
fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.40.36.48.37" ]
  ] ) ; # 
  fhir:version [ fhir:v "2.0.0-ballot"] ; # 
  fhir:name [ fhir:v "PqcmcQualitySpecificationSectionTypes"] ; # 
  fhir:title [ fhir:v "Specification Section Type Terminology"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:experimental [ fhir:v "false"^^xsd:boolean] ; # 
  fhir:date [ fhir:v "2024-12-12T19:00:52+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:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "brr@lists.HL7.org" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "Local value set of all codes in Specification Type codes"] ; # 
  fhir:jurisdiction ( [
    ( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "US" ] ;
fhir:display [ fhir:v "United States of America" ]     ] )
  ] ) ; # 
  fhir:compose [
    ( fhir:include [
fhir:system [ fhir:v "http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use"^^xsd:anyURI ] ;
      ( fhir:concept [
fhir:code [ fhir:v "ich_3.2.p.5.1" ] ;
fhir:display [ fhir:v "Specification(s)" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.4.1" ] ;
fhir:display [ fhir:v "Specification" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.4" ] ;
fhir:display [ fhir:v "Control of Excipients" ]       ] )     ] )
  ] . #