Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot United States of America flag

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

: Example Composition for CTD 3.2.S.2.3 - XML Representation

Raw xml | Download



<Composition xmlns="http://hl7.org/fhir">
  <id value="5c0d341e-6e4f-457c-811d-cfaf3eb62ecd"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23"/>
  </meta>
  <text>
    <status value="generated"/>
    <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>
  </text>
  <identifier>
    <value value="materials1"/>
  </identifier>
  <status value="final"/>
  <type>
    <coding>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"/>
      <code value="32S23"/>
      <display value="Substance Control of Materials"/>
    </coding>
  </type>
  <subject>
    <reference value="urn:uuid:cd84a8b5-4e96-551c-15c6-c97c943eb38a"/>
  </subject>
  <date value="2023-12-05T01:34:39.502Z"/>
  <author>
    <reference value="urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519"/>
  </author>
  <title value="Control of Materials Example"/>
  <section>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"/>
        <code value="32S231"/>
        <display value="Raw Material Specification"/>
      </coding>
    </code>
    <entry>
      <reference value="urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e"/>
    </entry>
  </section>
  <section>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"/>
        <code value="32S231"/>
        <display value="Raw Material Specification"/>
      </coding>
    </code>
    <entry>
      <reference value="urn:uuid:a2cba634-a481-4b07-9bd4-62c7ada31e1b"/>
    </entry>
  </section>
  <section>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"/>
        <code value="32S231"/>
        <display value="Raw Material Specification"/>
      </coding>
    </code>
    <entry>
      <reference value="urn:uuid:5819b223-d3d2-419f-b617-b3a9a3625b89"/>
    </entry>
  </section>
</Composition>