Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
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
| Active as of 2024-12-04 |
<ValueSet xmlns="http://hl7.org/fhir">
<id value="cmc-comp-section-types-vs"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet cmc-comp-section-types-vs</b></p><a name="cmc-comp-section-types-vs"> </a><a name="hccmc-comp-section-types-vs"> </a><a name="cmc-comp-section-types-vs-en-US"> </a><ul><li>Include these codes as defined in <code>http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use</code><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>ich_3.2.s</td><td>Drug Substance</td></tr><tr><td>ich_3.2.s.1</td><td>General Information</td></tr><tr><td>ich_3.2.s.2</td><td>Manufacture</td></tr><tr><td>ich_3.2.s.2.1</td><td>Manufacturers</td></tr><tr><td>ich_3.2.s.2.2</td><td>Description of Manufacturing Process and Process Controls</td></tr><tr><td>ich_3.2.s.2.3</td><td>Control of Materials</td></tr><tr><td>ich_3.2.s.2.4</td><td>Controls of Critical Steps and Intermediates</td></tr><tr><td>ich_3.2.s.2.5</td><td>Process Validation and/or Evaluation</td></tr><tr><td>ich_3.2.s.2.6</td><td>Manufacturing Process Development</td></tr><tr><td>ich_3.2.s.3</td><td>Characterisation</td></tr><tr><td>ich_3.2.s.3.1</td><td>Elucidation of Structure and other Characteristics</td></tr><tr><td>ich_3.2.s.3.2</td><td>Impurities</td></tr><tr><td>ich_3.2.s.4</td><td>Control of Drug Substance</td></tr><tr><td>ich_3.2.s.4.1</td><td>Specification</td></tr><tr><td>ich_3.2.s.4.2</td><td>Analytical Procedures</td></tr><tr><td>ich_3.2.s.4.3</td><td>Validation of Analytical Procedures</td></tr><tr><td>ich_3.2.s.4.4</td><td>Batch Analyses</td></tr><tr><td>ich_3.2.s.4.5</td><td>Justification of Specification</td></tr><tr><td>ich_3.2.s.5</td><td>Reference Standards or Materials</td></tr><tr><td>ich_3.2.s.6</td><td>Container Closure System</td></tr><tr><td>ich_3.2.s.7</td><td>Stability</td></tr><tr><td>ich_3.2.s.7.1</td><td>Stability Summary and Conclusions</td></tr><tr><td>ich_3.2.s.7.2</td><td>Postapproval Stability Protocol and Stability Commitment</td></tr><tr><td>ich_3.2.s.7.3</td><td>Stability Data</td></tr><tr><td>ich_3.2.p</td><td>Drug Product</td></tr><tr><td>ich_3.2.p.1</td><td>Description and Composition of the Drug Product</td></tr><tr><td>ich_3.2.p.2</td><td>Pharmaceutical Development</td></tr><tr><td>ich_3.2.p.2.1</td><td>Components of the Drug Product</td></tr><tr><td>ich_3.2.p.2.2</td><td>Drug Product</td></tr><tr><td>ich_3.2.p.2.3</td><td>Manufacturing Process Development</td></tr><tr><td>ich_3.2.p.2.4</td><td>Container Closure System</td></tr><tr><td>ich_3.2.p.2.5</td><td>Microbiological Attributes</td></tr><tr><td>ich_3.2.p.2.6</td><td>Compatibility</td></tr><tr><td>ich_3.2.p.3</td><td>Manufacture</td></tr><tr><td>ich_3.2.p.3.1</td><td>Manufacturer(s)</td></tr><tr><td>ich_3.2.p.3.2</td><td>Batch Formula</td></tr><tr><td>ich_3.2.p.3.3</td><td>Description of Manufacturing Process and Process Controls</td></tr><tr><td>ich_3.2.p.3.4</td><td>Controls of Critical Steps and Intermediates</td></tr><tr><td>ich_3.2.p.3.5</td><td>Process Validation and/or Evaluation</td></tr><tr><td>ich_3.2.p.4</td><td>Control of Excipients</td></tr><tr><td>ich_3.2.p.4.1</td><td>Specification</td></tr><tr><td>ich_3.2.p.4.2</td><td>Analytical Procedures</td></tr><tr><td>ich_3.2.p.4.3</td><td>Validation of Analytical Procedures</td></tr><tr><td>ich_3.2.p.4.4</td><td>Justification of Specifications</td></tr><tr><td>ich_3.2.p.4.5</td><td>Excipients of Human or Animal Origin</td></tr><tr><td>ich_3.2.p.4.6</td><td>Novel Excipients</td></tr><tr><td>ich_3.2.p.5</td><td>Control of Drug Product</td></tr><tr><td>ich_3.2.p.5.1</td><td>Specification(s)</td></tr><tr><td>ich_3.2.p.5.2</td><td>Analytical Procedures</td></tr><tr><td>ich_3.2.p.5.3</td><td>Validation of Analytical Procedures</td></tr><tr><td>ich_3.2.p.5.4</td><td>Batch Analyses</td></tr><tr><td>ich_3.2.p.5.5</td><td>Characterisation of Impurities</td></tr><tr><td>ich_3.2.p.5.6</td><td>Justification of Specifications</td></tr><tr><td>ich_3.2.p.6</td><td>Reference Standards or Materials</td></tr><tr><td>ich_3.2.p.7</td><td>Container Closure System</td></tr><tr><td>ich_3.2.p.8</td><td>Stability</td></tr><tr><td>ich_3.2.p.8.1</td><td>Stability Summary and Conclusion</td></tr><tr><td>ich_3.2.p.8.2</td><td>Postapproval Stability Protocol and Stability Commitment</td></tr><tr><td>ich_3.2.p.8.3</td><td>Stability Data</td></tr><tr><td>ich_3.2.a</td><td>Appendices</td></tr><tr><td>ich_3.2.a.1</td><td>Facilities And Equipment</td></tr><tr><td>ich_3.2.a.2</td><td>Adventitious Agents Safety Evaluation</td></tr><tr><td>ich_3.2.a.3</td><td>Excipients</td></tr><tr><td>ich_3.2.r</td><td>Regional Information</td></tr><tr><td>ich_3.3</td><td>Literature References</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/cmc-comp-section-types-vs"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.40.36.48.2"/>
</identifier>
<version value="2.0.0-ballot"/>
<name value="CmcCompSectionTypesVS"/>
<title value="eCTD sections 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="Value set of all codes in Code system PQCMC Comp Section Types."/>
<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://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use"/>
<concept>
<code value="ich_3.2.s"/>
<display value="Drug Substance"/>
</concept>
<concept>
<code value="ich_3.2.s.1"/>
<display value="General Information"/>
</concept>
<concept>
<code value="ich_3.2.s.2"/>
<display value="Manufacture"/>
</concept>
<concept>
<code value="ich_3.2.s.2.1"/>
<display value="Manufacturers"/>
</concept>
<concept>
<code value="ich_3.2.s.2.2"/>
<display
value="Description of Manufacturing Process and Process Controls"/>
</concept>
<concept>
<code value="ich_3.2.s.2.3"/>
<display value="Control of Materials"/>
</concept>
<concept>
<code value="ich_3.2.s.2.4"/>
<display value="Controls of Critical Steps and Intermediates"/>
</concept>
<concept>
<code value="ich_3.2.s.2.5"/>
<display value="Process Validation and/or Evaluation"/>
</concept>
<concept>
<code value="ich_3.2.s.2.6"/>
<display value="Manufacturing Process Development"/>
</concept>
<concept>
<code value="ich_3.2.s.3"/>
<display value="Characterisation"/>
</concept>
<concept>
<code value="ich_3.2.s.3.1"/>
<display value="Elucidation of Structure and other Characteristics"/>
</concept>
<concept>
<code value="ich_3.2.s.3.2"/>
<display value="Impurities"/>
</concept>
<concept>
<code value="ich_3.2.s.4"/>
<display value="Control of Drug Substance"/>
</concept>
<concept>
<code value="ich_3.2.s.4.1"/>
<display value="Specification"/>
</concept>
<concept>
<code value="ich_3.2.s.4.2"/>
<display value="Analytical Procedures"/>
</concept>
<concept>
<code value="ich_3.2.s.4.3"/>
<display value="Validation of Analytical Procedures"/>
</concept>
<concept>
<code value="ich_3.2.s.4.4"/>
<display value="Batch Analyses"/>
</concept>
<concept>
<code value="ich_3.2.s.4.5"/>
<display value="Justification of Specification"/>
</concept>
<concept>
<code value="ich_3.2.s.5"/>
<display value="Reference Standards or Materials"/>
</concept>
<concept>
<code value="ich_3.2.s.6"/>
<display value="Container Closure System"/>
</concept>
<concept>
<code value="ich_3.2.s.7"/>
<display value="Stability"/>
</concept>
<concept>
<code value="ich_3.2.s.7.1"/>
<display value="Stability Summary and Conclusions"/>
</concept>
<concept>
<code value="ich_3.2.s.7.2"/>
<display
value="Postapproval Stability Protocol and Stability Commitment"/>
</concept>
<concept>
<code value="ich_3.2.s.7.3"/>
<display value="Stability Data"/>
</concept>
<concept>
<code value="ich_3.2.p"/>
<display value="Drug Product"/>
</concept>
<concept>
<code value="ich_3.2.p.1"/>
<display value="Description and Composition of the Drug Product"/>
</concept>
<concept>
<code value="ich_3.2.p.2"/>
<display value="Pharmaceutical Development"/>
</concept>
<concept>
<code value="ich_3.2.p.2.1"/>
<display value="Components of the Drug Product"/>
</concept>
<concept>
<code value="ich_3.2.p.2.2"/>
<display value="Drug Product"/>
</concept>
<concept>
<code value="ich_3.2.p.2.3"/>
<display value="Manufacturing Process Development"/>
</concept>
<concept>
<code value="ich_3.2.p.2.4"/>
<display value="Container Closure System"/>
</concept>
<concept>
<code value="ich_3.2.p.2.5"/>
<display value="Microbiological Attributes"/>
</concept>
<concept>
<code value="ich_3.2.p.2.6"/>
<display value="Compatibility"/>
</concept>
<concept>
<code value="ich_3.2.p.3"/>
<display value="Manufacture"/>
</concept>
<concept>
<code value="ich_3.2.p.3.1"/>
<display value="Manufacturer(s)"/>
</concept>
<concept>
<code value="ich_3.2.p.3.2"/>
<display value="Batch Formula"/>
</concept>
<concept>
<code value="ich_3.2.p.3.3"/>
<display
value="Description of Manufacturing Process and Process Controls"/>
</concept>
<concept>
<code value="ich_3.2.p.3.4"/>
<display value="Controls of Critical Steps and Intermediates"/>
</concept>
<concept>
<code value="ich_3.2.p.3.5"/>
<display value="Process Validation and/or Evaluation"/>
</concept>
<concept>
<code value="ich_3.2.p.4"/>
<display value="Control of Excipients"/>
</concept>
<concept>
<code value="ich_3.2.p.4.1"/>
<display value="Specification"/>
</concept>
<concept>
<code value="ich_3.2.p.4.2"/>
<display value="Analytical Procedures"/>
</concept>
<concept>
<code value="ich_3.2.p.4.3"/>
<display value="Validation of Analytical Procedures"/>
</concept>
<concept>
<code value="ich_3.2.p.4.4"/>
<display value="Justification of Specifications"/>
</concept>
<concept>
<code value="ich_3.2.p.4.5"/>
<display value="Excipients of Human or Animal Origin"/>
</concept>
<concept>
<code value="ich_3.2.p.4.6"/>
<display value="Novel Excipients"/>
</concept>
<concept>
<code value="ich_3.2.p.5"/>
<display value="Control of Drug Product"/>
</concept>
<concept>
<code value="ich_3.2.p.5.1"/>
<display value="Specification(s)"/>
</concept>
<concept>
<code value="ich_3.2.p.5.2"/>
<display value="Analytical Procedures"/>
</concept>
<concept>
<code value="ich_3.2.p.5.3"/>
<display value="Validation of Analytical Procedures"/>
</concept>
<concept>
<code value="ich_3.2.p.5.4"/>
<display value="Batch Analyses"/>
</concept>
<concept>
<code value="ich_3.2.p.5.5"/>
<display value="Characterisation of Impurities"/>
</concept>
<concept>
<code value="ich_3.2.p.5.6"/>
<display value="Justification of Specifications"/>
</concept>
<concept>
<code value="ich_3.2.p.6"/>
<display value="Reference Standards or Materials"/>
</concept>
<concept>
<code value="ich_3.2.p.7"/>
<display value="Container Closure System"/>
</concept>
<concept>
<code value="ich_3.2.p.8"/>
<display value="Stability"/>
</concept>
<concept>
<code value="ich_3.2.p.8.1"/>
<display value="Stability Summary and Conclusion"/>
</concept>
<concept>
<code value="ich_3.2.p.8.2"/>
<display
value="Postapproval Stability Protocol and Stability Commitment"/>
</concept>
<concept>
<code value="ich_3.2.p.8.3"/>
<display value="Stability Data"/>
</concept>
<concept>
<code value="ich_3.2.a"/>
<display value="Appendices"/>
</concept>
<concept>
<code value="ich_3.2.a.1"/>
<display value="Facilities And Equipment"/>
</concept>
<concept>
<code value="ich_3.2.a.2"/>
<display value="Adventitious Agents Safety Evaluation"/>
</concept>
<concept>
<code value="ich_3.2.a.3"/>
<display value="Excipients"/>
</concept>
<concept>
<code value="ich_3.2.r"/>
<display value="Regional Information"/>
</concept>
<concept>
<code value="ich_3.3"/>
<display value="Literature References"/>
</concept>
</include>
</compose>
</ValueSet>
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change