Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 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/ and changes regularly. See the Directory of published versions
| Draft as of 2024-03-04 |
<CodeSystem xmlns="http://hl7.org/fhir">
<id value="pqcmc-comp-section-types"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>This case-sensitive code system <code>http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td style="white-space:nowrap">32S10<a name="pqcmc-comp-section-types-32S10"> </a></td><td>Substance General Information</td></tr><tr><td style="white-space:nowrap">32S11<a name="pqcmc-comp-section-types-32S11"> </a></td><td>Substance Nomenclature</td></tr><tr><td style="white-space:nowrap">32S12<a name="pqcmc-comp-section-types-32S12"> </a></td><td>Substance Structure</td></tr><tr><td style="white-space:nowrap">32S13<a name="pqcmc-comp-section-types-32S13"> </a></td><td>Substance General Properties</td></tr><tr><td style="white-space:nowrap">32S20<a name="pqcmc-comp-section-types-32S20"> </a></td><td>Substance Manufacture</td></tr><tr><td style="white-space:nowrap">32S21<a name="pqcmc-comp-section-types-32S21"> </a></td><td>Substance Manufacturers</td></tr><tr><td style="white-space:nowrap">32S22<a name="pqcmc-comp-section-types-32S22"> </a></td><td>Substance Description of Manufacturing Process and Process Controls</td></tr><tr><td style="white-space:nowrap">32S23<a name="pqcmc-comp-section-types-32S23"> </a></td><td>Substance Control of Materials</td></tr><tr><td style="white-space:nowrap">32S231<a name="pqcmc-comp-section-types-32S231"> </a></td><td>Raw Material Specification</td></tr><tr><td style="white-space:nowrap">32S24<a name="pqcmc-comp-section-types-32S24"> </a></td><td>Substance Controls of Critical Steps and Intermediates</td></tr><tr><td style="white-space:nowrap">32S25<a name="pqcmc-comp-section-types-32S25"> </a></td><td>Substance Process Validation and/or Evaluation</td></tr><tr><td style="white-space:nowrap">32S26<a name="pqcmc-comp-section-types-32S26"> </a></td><td>Substance Manufacturing Process Development</td></tr><tr><td style="white-space:nowrap">32S30<a name="pqcmc-comp-section-types-32S30"> </a></td><td>Substance Characterization</td></tr><tr><td style="white-space:nowrap">32S31<a name="pqcmc-comp-section-types-32S31"> </a></td><td>Substance Elucidation of Structure and other Characteristics</td></tr><tr><td style="white-space:nowrap">32S32<a name="pqcmc-comp-section-types-32S32"> </a></td><td>Substance Impurities</td></tr><tr><td style="white-space:nowrap">32S40<a name="pqcmc-comp-section-types-32S40"> </a></td><td>Substance Control of Drug Substance</td></tr><tr><td style="white-space:nowrap">32S41<a name="pqcmc-comp-section-types-32S41"> </a></td><td>Substance Specification</td></tr><tr><td style="white-space:nowrap">32S42<a name="pqcmc-comp-section-types-32S42"> </a></td><td>Substance Analytical Procedures</td></tr><tr><td style="white-space:nowrap">32S43<a name="pqcmc-comp-section-types-32S43"> </a></td><td>Substance Validation of Analytical Procedures</td></tr><tr><td style="white-space:nowrap">32S44<a name="pqcmc-comp-section-types-32S44"> </a></td><td>Substance Batch Analyses</td></tr><tr><td style="white-space:nowrap">32S45<a name="pqcmc-comp-section-types-32S45"> </a></td><td>Substance Justification of Specification</td></tr><tr><td style="white-space:nowrap">32S50<a name="pqcmc-comp-section-types-32S50"> </a></td><td>Substance Reference Standards or Materials</td></tr><tr><td style="white-space:nowrap">32S60<a name="pqcmc-comp-section-types-32S60"> </a></td><td>Substance Container Closure System</td></tr><tr><td style="white-space:nowrap">32S70<a name="pqcmc-comp-section-types-32S70"> </a></td><td>Substance Stability</td></tr><tr><td style="white-space:nowrap">32S71<a name="pqcmc-comp-section-types-32S71"> </a></td><td>Substance Stability Summary and Conclusions</td></tr><tr><td style="white-space:nowrap">32S72<a name="pqcmc-comp-section-types-32S72"> </a></td><td>Substance Postapproval Stability Protocol and Stability Commitment</td></tr><tr><td style="white-space:nowrap">32S73<a name="pqcmc-comp-section-types-32S73"> </a></td><td>Substance Stability Data</td></tr><tr><td style="white-space:nowrap">32P10<a name="pqcmc-comp-section-types-32P10"> </a></td><td>Product Description and Composition of the Drug Product</td></tr><tr><td style="white-space:nowrap">32P11<a name="pqcmc-comp-section-types-32P11"> </a></td><td>Product Description</td></tr><tr><td style="white-space:nowrap">32P12<a name="pqcmc-comp-section-types-32P12"> </a></td><td>Product Composition</td></tr><tr><td style="white-space:nowrap">32P13<a name="pqcmc-comp-section-types-32P13"> </a></td><td>Product Container Closure Description</td></tr><tr><td style="white-space:nowrap">32P20<a name="pqcmc-comp-section-types-32P20"> </a></td><td>Product Pharmaceutical Development</td></tr><tr><td style="white-space:nowrap">32P21<a name="pqcmc-comp-section-types-32P21"> </a></td><td>Product Components of the Drug Product</td></tr><tr><td style="white-space:nowrap">32P22<a name="pqcmc-comp-section-types-32P22"> </a></td><td>Product Drug Product</td></tr><tr><td style="white-space:nowrap">32P23<a name="pqcmc-comp-section-types-32P23"> </a></td><td>Product Manufacturing Process Development</td></tr><tr><td style="white-space:nowrap">32P24<a name="pqcmc-comp-section-types-32P24"> </a></td><td>Product Container Closure System</td></tr><tr><td style="white-space:nowrap">32P25<a name="pqcmc-comp-section-types-32P25"> </a></td><td>Product Microbiological Attributes</td></tr><tr><td style="white-space:nowrap">32P26<a name="pqcmc-comp-section-types-32P26"> </a></td><td>Product Compatibility</td></tr><tr><td style="white-space:nowrap">32P30<a name="pqcmc-comp-section-types-32P30"> </a></td><td>Product Manufacture</td></tr><tr><td style="white-space:nowrap">32P31<a name="pqcmc-comp-section-types-32P31"> </a></td><td>Product Manufacturers</td></tr><tr><td style="white-space:nowrap">32P32<a name="pqcmc-comp-section-types-32P32"> </a></td><td>Product Batch Formula</td></tr><tr><td style="white-space:nowrap">32P33<a name="pqcmc-comp-section-types-32P33"> </a></td><td>Product Description of Manufacturing Process and Process Controls</td></tr><tr><td style="white-space:nowrap">32P34<a name="pqcmc-comp-section-types-32P34"> </a></td><td>Product Controls of Critical Steps and Intermediates</td></tr><tr><td style="white-space:nowrap">32P35<a name="pqcmc-comp-section-types-32P35"> </a></td><td>Product Process Validation and/or Evaluation</td></tr><tr><td style="white-space:nowrap">32P40<a name="pqcmc-comp-section-types-32P40"> </a></td><td>Product Control of Excipients</td></tr><tr><td style="white-space:nowrap">32P41<a name="pqcmc-comp-section-types-32P41"> </a></td><td>Excipients Specification</td></tr><tr><td style="white-space:nowrap">32P42<a name="pqcmc-comp-section-types-32P42"> </a></td><td>Product Analytical Procedures</td></tr><tr><td style="white-space:nowrap">32P43<a name="pqcmc-comp-section-types-32P43"> </a></td><td>Product Validation of Analytical Procedures</td></tr><tr><td style="white-space:nowrap">32P44<a name="pqcmc-comp-section-types-32P44"> </a></td><td>Product Justification of Specifications</td></tr><tr><td style="white-space:nowrap">32P45<a name="pqcmc-comp-section-types-32P45"> </a></td><td>Product Excipients of Human or Animal Origin</td></tr><tr><td style="white-space:nowrap">32P46<a name="pqcmc-comp-section-types-32P46"> </a></td><td>Product Novel Excipients</td></tr><tr><td style="white-space:nowrap">32P50<a name="pqcmc-comp-section-types-32P50"> </a></td><td>Product name dosage form</td></tr><tr><td style="white-space:nowrap">32P51<a name="pqcmc-comp-section-types-32P51"> </a></td><td>Product Specification</td></tr><tr><td style="white-space:nowrap">32P52<a name="pqcmc-comp-section-types-32P52"> </a></td><td>Product Analytical Procedures</td></tr><tr><td style="white-space:nowrap">32P53<a name="pqcmc-comp-section-types-32P53"> </a></td><td>Product Validation of Analytical Procedures</td></tr><tr><td style="white-space:nowrap">32P54<a name="pqcmc-comp-section-types-32P54"> </a></td><td>Product Batch Analyses</td></tr><tr><td style="white-space:nowrap">32P55<a name="pqcmc-comp-section-types-32P55"> </a></td><td>Product Characterization of Impurities</td></tr><tr><td style="white-space:nowrap">32P56<a name="pqcmc-comp-section-types-32P56"> </a></td><td>Product Justification of Specifications</td></tr><tr><td style="white-space:nowrap">32P60<a name="pqcmc-comp-section-types-32P60"> </a></td><td>Product Reference Standards or Materials</td></tr><tr><td style="white-space:nowrap">32P70<a name="pqcmc-comp-section-types-32P70"> </a></td><td>Product Container Closure System</td></tr><tr><td style="white-space:nowrap">32P80<a name="pqcmc-comp-section-types-32P80"> </a></td><td>Product Stability</td></tr><tr><td style="white-space:nowrap">32P81<a name="pqcmc-comp-section-types-32P81"> </a></td><td>Product Stability Summary and Conclusion</td></tr><tr><td style="white-space:nowrap">32P82<a name="pqcmc-comp-section-types-32P82"> </a></td><td>Product Postapproval Stability Protocol and Stability Commitment</td></tr><tr><td style="white-space:nowrap">32P83<a name="pqcmc-comp-section-types-32P83"> </a></td><td>Product Stability Data</td></tr><tr><td style="white-space:nowrap">SP4151<a name="pqcmc-comp-section-types-SP4151"> </a></td><td>Quality Specification</td></tr><tr><td style="white-space:nowrap">SP4454<a name="pqcmc-comp-section-types-SP4454"> </a></td><td>Batch Analyses</td></tr><tr><td style="white-space:nowrap">SP7383<a name="pqcmc-comp-section-types-SP7383"> </a></td><td>Stability Data</td></tr><tr><td style="white-space:nowrap">SP7181<a name="pqcmc-comp-section-types-SP7181"> </a></td><td>Stability Summary and Conclusion</td></tr></table></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/CodeSystem/pqcmc-comp-section-types"/>
<version value="0.1.20"/>
<name value="PqcmcCompSectionTypes"/>
<title value="Code System PQCMC Comp Section Types"/>
<status value="draft"/>
<experimental value="false"/>
<date value="2024-03-04T02:24:01+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="Classification of a section of a PQ/CMC composition/document generally based on eCTD Module 3 section numbering for product and substance. A composition can have many section codes."/>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="US"/>
<display value="United States of America"/>
</coding>
</jurisdiction>
<caseSensitive value="true"/>
<content value="complete"/>
<count value="68"/>
<concept>
<code value="32S10"/>
<display value="Substance General Information"/>
</concept>
<concept>
<code value="32S11"/>
<display value="Substance Nomenclature"/>
</concept>
<concept>
<code value="32S12"/>
<display value="Substance Structure"/>
</concept>
<concept>
<code value="32S13"/>
<display value="Substance General Properties"/>
</concept>
<concept>
<code value="32S20"/>
<display value="Substance Manufacture"/>
</concept>
<concept>
<code value="32S21"/>
<display value="Substance Manufacturers"/>
</concept>
<concept>
<code value="32S22"/>
<display
value="Substance Description of Manufacturing Process and Process Controls"/>
</concept>
<concept>
<code value="32S23"/>
<display value="Substance Control of Materials"/>
</concept>
<concept>
<code value="32S231"/>
<display value="Raw Material Specification"/>
</concept>
<concept>
<code value="32S24"/>
<display value="Substance Controls of Critical Steps and Intermediates"/>
</concept>
<concept>
<code value="32S25"/>
<display value="Substance Process Validation and/or Evaluation"/>
</concept>
<concept>
<code value="32S26"/>
<display value="Substance Manufacturing Process Development"/>
</concept>
<concept>
<code value="32S30"/>
<display value="Substance Characterization"/>
</concept>
<concept>
<code value="32S31"/>
<display
value="Substance Elucidation of Structure and other Characteristics"/>
</concept>
<concept>
<code value="32S32"/>
<display value="Substance Impurities"/>
</concept>
<concept>
<code value="32S40"/>
<display value="Substance Control of Drug Substance"/>
</concept>
<concept>
<code value="32S41"/>
<display value="Substance Specification"/>
</concept>
<concept>
<code value="32S42"/>
<display value="Substance Analytical Procedures"/>
</concept>
<concept>
<code value="32S43"/>
<display value="Substance Validation of Analytical Procedures"/>
</concept>
<concept>
<code value="32S44"/>
<display value="Substance Batch Analyses"/>
</concept>
<concept>
<code value="32S45"/>
<display value="Substance Justification of Specification"/>
</concept>
<concept>
<code value="32S50"/>
<display value="Substance Reference Standards or Materials"/>
</concept>
<concept>
<code value="32S60"/>
<display value="Substance Container Closure System"/>
</concept>
<concept>
<code value="32S70"/>
<display value="Substance Stability"/>
</concept>
<concept>
<code value="32S71"/>
<display value="Substance Stability Summary and Conclusions"/>
</concept>
<concept>
<code value="32S72"/>
<display
value="Substance Postapproval Stability Protocol and Stability Commitment"/>
</concept>
<concept>
<code value="32S73"/>
<display value="Substance Stability Data"/>
</concept>
<concept>
<code value="32P10"/>
<display value="Product Description and Composition of the Drug Product"/>
</concept>
<concept>
<code value="32P11"/>
<display value="Product Description"/>
</concept>
<concept>
<code value="32P12"/>
<display value="Product Composition"/>
</concept>
<concept>
<code value="32P13"/>
<display value="Product Container Closure Description"/>
</concept>
<concept>
<code value="32P20"/>
<display value="Product Pharmaceutical Development"/>
</concept>
<concept>
<code value="32P21"/>
<display value="Product Components of the Drug Product"/>
</concept>
<concept>
<code value="32P22"/>
<display value="Product Drug Product"/>
</concept>
<concept>
<code value="32P23"/>
<display value="Product Manufacturing Process Development"/>
</concept>
<concept>
<code value="32P24"/>
<display value="Product Container Closure System"/>
</concept>
<concept>
<code value="32P25"/>
<display value="Product Microbiological Attributes"/>
</concept>
<concept>
<code value="32P26"/>
<display value="Product Compatibility"/>
</concept>
<concept>
<code value="32P30"/>
<display value="Product Manufacture"/>
</concept>
<concept>
<code value="32P31"/>
<display value="Product Manufacturers"/>
</concept>
<concept>
<code value="32P32"/>
<display value="Product Batch Formula"/>
</concept>
<concept>
<code value="32P33"/>
<display
value="Product Description of Manufacturing Process and Process Controls"/>
</concept>
<concept>
<code value="32P34"/>
<display value="Product Controls of Critical Steps and Intermediates"/>
</concept>
<concept>
<code value="32P35"/>
<display value="Product Process Validation and/or Evaluation"/>
</concept>
<concept>
<code value="32P40"/>
<display value="Product Control of Excipients"/>
</concept>
<concept>
<code value="32P41"/>
<display value="Excipients Specification"/>
</concept>
<concept>
<code value="32P42"/>
<display value="Product Analytical Procedures"/>
</concept>
<concept>
<code value="32P43"/>
<display value="Product Validation of Analytical Procedures"/>
</concept>
<concept>
<code value="32P44"/>
<display value="Product Justification of Specifications"/>
</concept>
<concept>
<code value="32P45"/>
<display value="Product Excipients of Human or Animal Origin"/>
</concept>
<concept>
<code value="32P46"/>
<display value="Product Novel Excipients"/>
</concept>
<concept>
<code value="32P50"/>
<display value="Product name dosage form"/>
</concept>
<concept>
<code value="32P51"/>
<display value="Product Specification"/>
</concept>
<concept>
<code value="32P52"/>
<display value="Product Analytical Procedures"/>
</concept>
<concept>
<code value="32P53"/>
<display value="Product Validation of Analytical Procedures"/>
</concept>
<concept>
<code value="32P54"/>
<display value="Product Batch Analyses"/>
</concept>
<concept>
<code value="32P55"/>
<display value="Product Characterization of Impurities"/>
</concept>
<concept>
<code value="32P56"/>
<display value="Product Justification of Specifications"/>
</concept>
<concept>
<code value="32P60"/>
<display value="Product Reference Standards or Materials"/>
</concept>
<concept>
<code value="32P70"/>
<display value="Product Container Closure System"/>
</concept>
<concept>
<code value="32P80"/>
<display value="Product Stability"/>
</concept>
<concept>
<code value="32P81"/>
<display value="Product Stability Summary and Conclusion"/>
</concept>
<concept>
<code value="32P82"/>
<display
value="Product Postapproval Stability Protocol and Stability Commitment"/>
</concept>
<concept>
<code value="32P83"/>
<display value="Product Stability Data"/>
</concept>
<concept>
<code value="SP4151"/>
<display value="Quality Specification"/>
</concept>
<concept>
<code value="SP4454"/>
<display value="Batch Analyses"/>
</concept>
<concept>
<code value="SP7383"/>
<display value="Stability Data"/>
</concept>
<concept>
<code value="SP7181"/>
<display value="Stability Summary and Conclusion"/>
</concept>
</CodeSystem>
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#0.1.20 based on FHIR 5.0.0. Generated 2024-03-04
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