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

: IngredComponentSubstance example showing the use of the sourceMaterial backbone element - 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:SubstanceDefinition ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "496f83ad-2365-4b12-8672-a349d99f7d67"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"496f83ad-2365-4b12-8672-a349d99f7d67\"> </a><a name=\"hc496f83ad-2365-4b12-8672-a349d99f7d67\"> </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 SubstanceDefinition &quot;496f83ad-2365-4b12-8672-a349d99f7d67&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-component-substance.html\">Component Substance</a></p></div><p><b>identifier</b>: Grape skin extract</p><p><b>classification</b>: Mixture <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C45305)</span></p><p><b>grade</b>: BP <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C176793)</span></p><p><b>manufacturer</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</a></p><p><b>supplier</b>: <a href=\"Bundle-bd0f0a7a-27ea-4884-801d-bd0546e80888.html#urn-uuid-8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9\">urn:uuid:8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>3GOV20705G <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html\">Unique Ingredient Identifier (UNII)</a>#3GOV20705G)</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>WINE GRAPE</td><td>GSRS Preferred Term <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C203355)</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Genus</b></td><td><b>Species</b></td><td><b>Part</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style=\"display: none\">*</td><td>Plant <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C14258)</span></td><td>Vitis <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>vinifera <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>skin <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>United States of America <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#USA)</span></td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:value [ fhir:v "Grape skin extract" ]
  ] ) ; # 
  fhir:classification ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C45305" ] ;
fhir:display [ fhir:v "Mixture" ]     ] )
  ] ) ; # 
  fhir:grade ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C176793" ] ;
fhir:display [ fhir:v "BP" ]     ] )
  ] ) ; # 
  fhir:manufacturer ( [
fhir:reference [ fhir:v "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049" ]
  ] ) ; # 
  fhir:supplier ( [
fhir:reference [ fhir:v "urn:uuid:8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9" ]
  ] ) ; # 
  fhir:code ( [
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "3GOV20705G" ]       ] )     ]
  ] ) ; # 
  fhir:name ( [
fhir:name [ fhir:v "WINE GRAPE" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C203355" ] ;
fhir:display [ fhir:v "GSRS Preferred Term" ]       ] )     ] ;
fhir:preferred [ fhir:v "true"^^xsd:boolean ]
  ] ) ; # 
  fhir:sourceMaterial [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C14258" ] ;
fhir:display [ fhir:v "Plant" ]       ] )     ] ;
fhir:genus [
fhir:text [ fhir:v "Vitis" ]     ] ;
fhir:species [
fhir:text [ fhir:v "vinifera" ]     ] ;
fhir:part [
fhir:text [ fhir:v "skin" ]     ] ;
    ( fhir:countryOfOrigin [
      ( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "USA" ] ;
fhir:display [ fhir:v "United States of America" ]       ] )     ] )
  ] . #