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 - XML Representation

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<Composition xmlns="http://hl7.org/fhir">
  <id value="55d92f43-e328-4011-bbcf-744e3afd954f"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151"/>
  </meta>
  <text>
    <status value="generated"/>
    <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>
  </text>
  <identifier>
    <value value="ExampleSpecification2"/>
  </identifier>
  <status value="final"/>
  <type>
    <coding>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"/>
      <code value="SP4151"/>
      <display value="Quality Specification"/>
    </coding>
  </type>
  <date value="2023-12-15T22:36:51.299Z"/>
  <author>
    <reference value="urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"/>
  </author>
  <title value="Quality Specification for an API"/>
  <section>
    <title value="32S41"/>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"/>
        <code value="32S41"/>
        <display value="Substance Specification"/>
      </coding>
    </code>
    <entry>
      <reference value="urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"/>
    </entry>
  </section>
</Composition>