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Active as of 2024-12-12 |
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
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fhir:text [
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fhir:div "<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>"
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( fhir:include [
fhir:system [ fhir:v "http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use"^^xsd:anyURI ] ;
( fhir:concept [
fhir:code [ fhir:v "ich_3.2.s" ] ;
fhir:display [ fhir:v "Drug Substance" ] ] [
fhir:code [ fhir:v "ich_3.2.s.1" ] ;
fhir:display [ fhir:v "General Information" ] ] [
fhir:code [ fhir:v "ich_3.2.s.2" ] ;
fhir:display [ fhir:v "Manufacture" ] ] [
fhir:code [ fhir:v "ich_3.2.s.2.1" ] ;
fhir:display [ fhir:v "Manufacturers" ] ] [
fhir:code [ fhir:v "ich_3.2.s.2.2" ] ;
fhir:display [ fhir:v "Description of Manufacturing Process and Process Controls" ] ] [
fhir:code [ fhir:v "ich_3.2.s.2.3" ] ;
fhir:display [ fhir:v "Control of Materials" ] ] [
fhir:code [ fhir:v "ich_3.2.s.2.4" ] ;
fhir:display [ fhir:v "Controls of Critical Steps and Intermediates" ] ] [
fhir:code [ fhir:v "ich_3.2.s.2.5" ] ;
fhir:display [ fhir:v "Process Validation and/or Evaluation" ] ] [
fhir:code [ fhir:v "ich_3.2.s.2.6" ] ;
fhir:display [ fhir:v "Manufacturing Process Development" ] ] [
fhir:code [ fhir:v "ich_3.2.s.3" ] ;
fhir:display [ fhir:v "Characterisation" ] ] [
fhir:code [ fhir:v "ich_3.2.s.3.1" ] ;
fhir:display [ fhir:v "Elucidation of Structure and other Characteristics" ] ] [
fhir:code [ fhir:v "ich_3.2.s.3.2" ] ;
fhir:display [ fhir:v "Impurities" ] ] [
fhir:code [ fhir:v "ich_3.2.s.4" ] ;
fhir:display [ fhir:v "Control of Drug Substance" ] ] [
fhir:code [ fhir:v "ich_3.2.s.4.1" ] ;
fhir:display [ fhir:v "Specification" ] ] [
fhir:code [ fhir:v "ich_3.2.s.4.2" ] ;
fhir:display [ fhir:v "Analytical Procedures" ] ] [
fhir:code [ fhir:v "ich_3.2.s.4.3" ] ;
fhir:display [ fhir:v "Validation of Analytical Procedures" ] ] [
fhir:code [ fhir:v "ich_3.2.s.4.4" ] ;
fhir:display [ fhir:v "Batch Analyses" ] ] [
fhir:code [ fhir:v "ich_3.2.s.4.5" ] ;
fhir:display [ fhir:v "Justification of Specification" ] ] [
fhir:code [ fhir:v "ich_3.2.s.5" ] ;
fhir:display [ fhir:v "Reference Standards or Materials" ] ] [
fhir:code [ fhir:v "ich_3.2.s.6" ] ;
fhir:display [ fhir:v "Container Closure System" ] ] [
fhir:code [ fhir:v "ich_3.2.s.7" ] ;
fhir:display [ fhir:v "Stability" ] ] [
fhir:code [ fhir:v "ich_3.2.s.7.1" ] ;
fhir:display [ fhir:v "Stability Summary and Conclusions" ] ] [
fhir:code [ fhir:v "ich_3.2.s.7.2" ] ;
fhir:display [ fhir:v "Postapproval Stability Protocol and Stability Commitment" ] ] [
fhir:code [ fhir:v "ich_3.2.s.7.3" ] ;
fhir:display [ fhir:v "Stability Data" ] ] [
fhir:code [ fhir:v "ich_3.2.p" ] ;
fhir:display [ fhir:v "Drug Product" ] ] [
fhir:code [ fhir:v "ich_3.2.p.1" ] ;
fhir:display [ fhir:v "Description and Composition of the Drug Product" ] ] [
fhir:code [ fhir:v "ich_3.2.p.2" ] ;
fhir:display [ fhir:v "Pharmaceutical Development" ] ] [
fhir:code [ fhir:v "ich_3.2.p.2.1" ] ;
fhir:display [ fhir:v "Components of the Drug Product" ] ] [
fhir:code [ fhir:v "ich_3.2.p.2.2" ] ;
fhir:display [ fhir:v "Drug Product" ] ] [
fhir:code [ fhir:v "ich_3.2.p.2.3" ] ;
fhir:display [ fhir:v "Manufacturing Process Development" ] ] [
fhir:code [ fhir:v "ich_3.2.p.2.4" ] ;
fhir:display [ fhir:v "Container Closure System" ] ] [
fhir:code [ fhir:v "ich_3.2.p.2.5" ] ;
fhir:display [ fhir:v "Microbiological Attributes" ] ] [
fhir:code [ fhir:v "ich_3.2.p.2.6" ] ;
fhir:display [ fhir:v "Compatibility" ] ] [
fhir:code [ fhir:v "ich_3.2.p.3" ] ;
fhir:display [ fhir:v "Manufacture" ] ] [
fhir:code [ fhir:v "ich_3.2.p.3.1" ] ;
fhir:display [ fhir:v "Manufacturer(s)" ] ] [
fhir:code [ fhir:v "ich_3.2.p.3.2" ] ;
fhir:display [ fhir:v "Batch Formula" ] ] [
fhir:code [ fhir:v "ich_3.2.p.3.3" ] ;
fhir:display [ fhir:v "Description of Manufacturing Process and Process Controls" ] ] [
fhir:code [ fhir:v "ich_3.2.p.3.4" ] ;
fhir:display [ fhir:v "Controls of Critical Steps and Intermediates" ] ] [
fhir:code [ fhir:v "ich_3.2.p.3.5" ] ;
fhir:display [ fhir:v "Process Validation and/or Evaluation" ] ] [
fhir:code [ fhir:v "ich_3.2.p.4" ] ;
fhir:display [ fhir:v "Control of Excipients" ] ] [
fhir:code [ fhir:v "ich_3.2.p.4.1" ] ;
fhir:display [ fhir:v "Specification" ] ] [
fhir:code [ fhir:v "ich_3.2.p.4.2" ] ;
fhir:display [ fhir:v "Analytical Procedures" ] ] [
fhir:code [ fhir:v "ich_3.2.p.4.3" ] ;
fhir:display [ fhir:v "Validation of Analytical Procedures" ] ] [
fhir:code [ fhir:v "ich_3.2.p.4.4" ] ;
fhir:display [ fhir:v "Justification of Specifications" ] ] [
fhir:code [ fhir:v "ich_3.2.p.4.5" ] ;
fhir:display [ fhir:v "Excipients of Human or Animal Origin" ] ] [
fhir:code [ fhir:v "ich_3.2.p.4.6" ] ;
fhir:display [ fhir:v "Novel Excipients" ] ] [
fhir:code [ fhir:v "ich_3.2.p.5" ] ;
fhir:display [ fhir:v "Control of Drug Product" ] ] [
fhir:code [ fhir:v "ich_3.2.p.5.1" ] ;
fhir:display [ fhir:v "Specification(s)" ] ] [
fhir:code [ fhir:v "ich_3.2.p.5.2" ] ;
fhir:display [ fhir:v "Analytical Procedures" ] ] [
fhir:code [ fhir:v "ich_3.2.p.5.3" ] ;
fhir:display [ fhir:v "Validation of Analytical Procedures" ] ] [
fhir:code [ fhir:v "ich_3.2.p.5.4" ] ;
fhir:display [ fhir:v "Batch Analyses" ] ] [
fhir:code [ fhir:v "ich_3.2.p.5.5" ] ;
fhir:display [ fhir:v "Characterisation of Impurities" ] ] [
fhir:code [ fhir:v "ich_3.2.p.5.6" ] ;
fhir:display [ fhir:v "Justification of Specifications" ] ] [
fhir:code [ fhir:v "ich_3.2.p.6" ] ;
fhir:display [ fhir:v "Reference Standards or Materials" ] ] [
fhir:code [ fhir:v "ich_3.2.p.7" ] ;
fhir:display [ fhir:v "Container Closure System" ] ] [
fhir:code [ fhir:v "ich_3.2.p.8" ] ;
fhir:display [ fhir:v "Stability" ] ] [
fhir:code [ fhir:v "ich_3.2.p.8.1" ] ;
fhir:display [ fhir:v "Stability Summary and Conclusion" ] ] [
fhir:code [ fhir:v "ich_3.2.p.8.2" ] ;
fhir:display [ fhir:v "Postapproval Stability Protocol and Stability Commitment" ] ] [
fhir:code [ fhir:v "ich_3.2.p.8.3" ] ;
fhir:display [ fhir:v "Stability Data" ] ] [
fhir:code [ fhir:v "ich_3.2.a" ] ;
fhir:display [ fhir:v "Appendices" ] ] [
fhir:code [ fhir:v "ich_3.2.a.1" ] ;
fhir:display [ fhir:v "Facilities And Equipment" ] ] [
fhir:code [ fhir:v "ich_3.2.a.2" ] ;
fhir:display [ fhir:v "Adventitious Agents Safety Evaluation" ] ] [
fhir:code [ fhir:v "ich_3.2.a.3" ] ;
fhir:display [ fhir:v "Excipients" ] ] [
fhir:code [ fhir:v "ich_3.2.r" ] ;
fhir:display [ fhir:v "Regional Information" ] ] [
fhir:code [ fhir:v "ich_3.3" ] ;
fhir:display [ fhir:v "Literature References" ] ] ) ] )
] . #
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 2024-12-12
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