Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

: eCTD Drug Substance Specification Composition SP4151 - JSON Representation

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{
  "resourceType" : "Composition",
  "id" : "55d92f43-e328-4011-bbcf-744e3afd954f",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151"
    ]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Composition</b><a name=\"55d92f43-e328-4011-bbcf-744e3afd954f\"> </a><a name=\"hc55d92f43-e328-4011-bbcf-744e3afd954f\"> </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;55d92f43-e328-4011-bbcf-744e3afd954f&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>: ExampleSpecification2</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 22:36:51+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 API</p></div>"
  },
  "identifier" : [
    {
      "value" : "ExampleSpecification2"
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  ],
  "status" : "final",
  "type" : {
    "coding" : [
      {
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
        "code" : "SP4151",
        "display" : "Quality Specification"
      }
    ]
  },
  "date" : "2023-12-15T22:36:51.299Z",
  "author" : [
    {
      "reference" : "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"
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  ],
  "title" : "Quality Specification for an API",
  "section" : [
    {
      "title" : "32S41",
      "code" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
            "code" : "32S41",
            "display" : "Substance Specification"
          }
        ]
      },
      "entry" : [
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}