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 2.0.0-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

: Impurity Classification Terminology - XML Representation

Active as of 2024-12-04

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="pqcmc-impurity-classification-terminology"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet pqcmc-impurity-classification-terminology</b></p><a name="pqcmc-impurity-classification-terminology"> </a><a name="hcpqcmc-impurity-classification-terminology"> </a><a name="pqcmc-impurity-classification-terminology-en-US"> </a><ul><li>Include these codes as defined in <a href="http://terminology.hl7.org/6.1.0/CodeSystem-v3-nciThesaurus.html"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C176816</td><td>Degradation Product</td></tr><tr><td>C185190</td><td>Elemental Impurities</td></tr><tr><td>C176815</td><td>Residual Solvent</td></tr><tr><td>C134001</td><td>Inorganic</td></tr><tr><td>C176812</td><td>Process Related/Process</td></tr><tr><td>C185192</td><td>Leachables</td></tr><tr><td>C176813</td><td>Product Related</td></tr><tr><td>C92081</td><td>Microbiological</td></tr></table></li></ul></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <url
       value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-impurity-classification-terminology"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.40.36.48.36"/>
  </identifier>
  <version value="2.0.0-ballot"/>
  <name value="PqcmcImpurityClassificationTerminology"/>
  <title value="Impurity Classification Terminology"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2024-12-04T20:50:29+00:00"/>
  <publisher value="HL7 International / Biomedical Research and Regulation"/>
  <contact>
    <name value="HL7 International / Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="brr@lists.HL7.org"/>
    </telecom>
  </contact>
  <description
               value="Terminology used to qualify the information pertaining to impurity classifications in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."/>
  <jurisdiction>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="US"/>
      <display value="United States of America"/>
    </coding>
  </jurisdiction>
  <compose>
    <include>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <concept>
        <code value="C176816"/>
        <display value="Degradation Product"/>
      </concept>
      <concept>
        <code value="C185190"/>
        <display value="Elemental Impurities"/>
      </concept>
      <concept>
        <code value="C176815"/>
        <display value="Residual Solvent"/>
      </concept>
      <concept>
        <code value="C134001"/>
        <display value="Inorganic"/>
      </concept>
      <concept>
        <code value="C176812"/>
        <display value="Process Related/Process"/>
      </concept>
      <concept>
        <code value="C185192"/>
        <display value="Leachables"/>
      </concept>
      <concept>
        <code value="C176813"/>
        <display value="Product Related"/>
      </concept>
      <concept>
        <code value="C92081"/>
        <display value="Microbiological"/>
      </concept>
    </include>
  </compose>
</ValueSet>