Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, 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-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

: eCTD Product Specification Composition SP4151 - TTL Representation

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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:Composition ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "d332acdf-4874-407b-9950-528f14c6bea2"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Composition</b><a name=\"d332acdf-4874-407b-9950-528f14c6bea2\"> </a><a name=\"hcd332acdf-4874-407b-9950-528f14c6bea2\"> </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 Composition &quot;d332acdf-4874-407b-9950-528f14c6bea2&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ectd-composition-sp4151.html\">eCTD Specification Composition</a></p></div><p><b>identifier</b>: ExampleSpecification</p><p><b>status</b>: final</p><p><b>type</b>: Quality Specification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pqcmc-comp-section-types.html\">Code System PQCMC Comp Section Types</a>#SP4151)</span></p><p><b>date</b>: 2023-12-15 22:33:13+0000</p><p><b>author</b>: <a href=\"Bundle-4a7e17c1-a611-4cc7-9a71-8005a8b427ab.html#urn-uuid-4f3e9af1-306b-4fad-bf04-7881400b266a\">urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a</a></p><p><b>title</b>: Quality Specification for an example Drug Product</p></div>"
  ] ; # 
  fhir:identifier ( [
fhir:value [ fhir:v "ExampleSpecification" ]
  ] ) ; # 
  fhir:status [ fhir:v "final"] ; # 
  fhir:type [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"^^xsd:anyURI ] ;
fhir:code [ fhir:v "SP4151" ] ;
fhir:display [ fhir:v "Quality Specification" ]     ] )
  ] ; # 
  fhir:date [ fhir:v "2023-12-15T22:33:13.089Z"^^xsd:dateTime] ; # 
  fhir:author ( [
fhir:reference [ fhir:v "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a" ]
  ] ) ; # 
  fhir:title [ fhir:v "Quality Specification for an example Drug Product"] ; # 
  fhir:section ( [
fhir:title [ fhir:v "32P51" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"^^xsd:anyURI ] ;
fhir:code [ fhir:v "32P51" ] ;
fhir:display [ fhir:v "Product Specification" ]       ] )     ] ;
    ( fhir:entry [
fhir:reference [ fhir:v "urn:uuid:aa514363-d43f-4052-b44e-b67aa4d6dee7" ]     ] )
  ] ) . #