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 |
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"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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{
"code" : "ich_3.2.s.1",
"display" : "General Information"
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{
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"display" : "Manufacture"
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{
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"display" : "Manufacturers"
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"display" : "Description of Manufacturing Process and Process Controls"
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{
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"display" : "Control of Materials"
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"display" : "Controls of Critical Steps and Intermediates"
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"display" : "Manufacturing Process Development"
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"display" : "Characterisation"
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{
"code" : "ich_3.2.s.3.1",
"display" : "Elucidation of Structure and other Characteristics"
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{
"code" : "ich_3.2.s.3.2",
"display" : "Impurities"
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{
"code" : "ich_3.2.s.4",
"display" : "Control of Drug Substance"
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{
"code" : "ich_3.2.s.4.1",
"display" : "Specification"
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{
"code" : "ich_3.2.s.4.2",
"display" : "Analytical Procedures"
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{
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"display" : "Validation of Analytical Procedures"
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{
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"display" : "Batch Analyses"
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"display" : "Justification of Specification"
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{
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"display" : "Reference Standards or Materials"
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{
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"display" : "Container Closure System"
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"display" : "Microbiological Attributes"
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"display" : "Compatibility"
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{
"code" : "ich_3.2.p.3",
"display" : "Manufacture"
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{
"code" : "ich_3.2.p.3.1",
"display" : "Manufacturer(s)"
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{
"code" : "ich_3.2.p.3.2",
"display" : "Batch Formula"
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{
"code" : "ich_3.2.p.3.3",
"display" : "Description of Manufacturing Process and Process Controls"
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"display" : "Controls of Critical Steps and Intermediates"
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"display" : "Process Validation and/or Evaluation"
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"display" : "Control of Excipients"
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{
"code" : "ich_3.2.p.4.1",
"display" : "Specification"
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{
"code" : "ich_3.2.p.4.2",
"display" : "Analytical Procedures"
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{
"code" : "ich_3.2.p.4.3",
"display" : "Validation of Analytical Procedures"
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{
"code" : "ich_3.2.p.4.4",
"display" : "Justification of Specifications"
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{
"code" : "ich_3.2.p.4.5",
"display" : "Excipients of Human or Animal Origin"
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{
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"display" : "Novel Excipients"
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{
"code" : "ich_3.2.p.5",
"display" : "Control of Drug Product"
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{
"code" : "ich_3.2.p.5.1",
"display" : "Specification(s)"
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{
"code" : "ich_3.2.p.5.2",
"display" : "Analytical Procedures"
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{
"code" : "ich_3.2.p.5.3",
"display" : "Validation of Analytical Procedures"
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{
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"display" : "Batch Analyses"
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{
"code" : "ich_3.2.p.5.5",
"display" : "Characterisation of Impurities"
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{
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"display" : "Justification of Specifications"
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{
"code" : "ich_3.2.p.6",
"display" : "Reference Standards or Materials"
},
{
"code" : "ich_3.2.p.7",
"display" : "Container Closure System"
},
{
"code" : "ich_3.2.p.8",
"display" : "Stability"
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{
"code" : "ich_3.2.p.8.1",
"display" : "Stability Summary and Conclusion"
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{
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"display" : "Postapproval Stability Protocol and Stability Commitment"
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{
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"display" : "Stability Data"
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{
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"display" : "Appendices"
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"display" : "Facilities And Equipment"
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{
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"display" : "Adventitious Agents Safety Evaluation"
},
{
"code" : "ich_3.2.a.3",
"display" : "Excipients"
},
{
"code" : "ich_3.2.r",
"display" : "Regional Information"
},
{
"code" : "ich_3.3",
"display" : "Literature References"
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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
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