Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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: Example Composition for CTD 3.2.S.2.3 - JSON Representation

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{
  "resourceType" : "Composition",
  "id" : "5c0d341e-6e4f-457c-811d-cfaf3eb62ecd",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23"
    ]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Composition</b><a name=\"5c0d341e-6e4f-457c-811d-cfaf3eb62ecd\"> </a><a name=\"hc5c0d341e-6e4f-457c-811d-cfaf3eb62ecd\"> </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;5c0d341e-6e4f-457c-811d-cfaf3eb62ecd&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ectd-composition-32s23.html\">eCTD Substance Control of Materials Composition</a></p></div><p><b>identifier</b>: materials1</p><p><b>status</b>: final</p><p><b>type</b>: Substance Control of Materials <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>#32S23)</span></p><p><b>date</b>: 2023-12-05 01:34:39+0000</p><p><b>author</b>: <a href=\"Bundle-7ce2088d-d281-4e2f-9a25-120a1f9805d1.html#urn-uuid-49438799-e286-432c-b8d8-68ac77e7f519\">urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519</a></p><p><b>title</b>: Control of Materials Example</p></div>"
  },
  "identifier" : [
    {
      "value" : "materials1"
    }
  ],
  "status" : "final",
  "type" : {
    "coding" : [
      {
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
        "code" : "32S23",
        "display" : "Substance Control of Materials"
      }
    ]
  },
  "subject" : [
    {
      "reference" : "urn:uuid:cd84a8b5-4e96-551c-15c6-c97c943eb38a"
    }
  ],
  "date" : "2023-12-05T01:34:39.502Z",
  "author" : [
    {
      "reference" : "urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519"
    }
  ],
  "title" : "Control of Materials Example",
  "section" : [
    {
      "code" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
            "code" : "32S231",
            "display" : "Raw Material Specification"
          }
        ]
      },
      "entry" : [
        {
          "reference" : "urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e"
        }
      ]
    },
    {
      "code" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
            "code" : "32S231",
            "display" : "Raw Material Specification"
          }
        ]
      },
      "entry" : [
        {
          "reference" : "urn:uuid:a2cba634-a481-4b07-9bd4-62c7ada31e1b"
        }
      ]
    },
    {
      "code" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
            "code" : "32S231",
            "display" : "Raw Material Specification"
          }
        ]
      },
      "entry" : [
        {
          "reference" : "urn:uuid:5819b223-d3d2-419f-b617-b3a9a3625b89"
        }
      ]
    }
  ]
}