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 |
{
"resourceType" : "CodeSystem",
"id" : "pqcmc-comp-section-types",
"text" : {
"status" : "generated",
"div" : "<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>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
}
],
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
"version" : "0.1.20",
"name" : "PqcmcCompSectionTypes",
"title" : "Code System PQCMC Comp Section Types",
"status" : "draft",
"experimental" : false,
"date" : "2024-03-04T02:24:01+00:00",
"publisher" : "HL7 International / Biomedical Research and Regulation",
"contact" : [
{
"name" : "HL7 International / Biomedical Research and Regulation",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/rcrim"
},
{
"system" : "email",
"value" : "brr@lists.HL7.org"
}
]
}
],
"description" : "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" : "urn:iso:std:iso:3166",
"code" : "US",
"display" : "United States of America"
}
]
}
],
"caseSensitive" : true,
"content" : "complete",
"count" : 68,
"concept" : [
{
"code" : "32S10",
"display" : "Substance General Information"
},
{
"code" : "32S11",
"display" : "Substance Nomenclature"
},
{
"code" : "32S12",
"display" : "Substance Structure"
},
{
"code" : "32S13",
"display" : "Substance General Properties"
},
{
"code" : "32S20",
"display" : "Substance Manufacture"
},
{
"code" : "32S21",
"display" : "Substance Manufacturers"
},
{
"code" : "32S22",
"display" : "Substance Description of Manufacturing Process and Process Controls"
},
{
"code" : "32S23",
"display" : "Substance Control of Materials"
},
{
"code" : "32S231",
"display" : "Raw Material Specification"
},
{
"code" : "32S24",
"display" : "Substance Controls of Critical Steps and Intermediates"
},
{
"code" : "32S25",
"display" : "Substance Process Validation and/or Evaluation"
},
{
"code" : "32S26",
"display" : "Substance Manufacturing Process Development"
},
{
"code" : "32S30",
"display" : "Substance Characterization"
},
{
"code" : "32S31",
"display" : "Substance Elucidation of Structure and other Characteristics"
},
{
"code" : "32S32",
"display" : "Substance Impurities"
},
{
"code" : "32S40",
"display" : "Substance Control of Drug Substance"
},
{
"code" : "32S41",
"display" : "Substance Specification"
},
{
"code" : "32S42",
"display" : "Substance Analytical Procedures"
},
{
"code" : "32S43",
"display" : "Substance Validation of Analytical Procedures"
},
{
"code" : "32S44",
"display" : "Substance Batch Analyses"
},
{
"code" : "32S45",
"display" : "Substance Justification of Specification"
},
{
"code" : "32S50",
"display" : "Substance Reference Standards or Materials"
},
{
"code" : "32S60",
"display" : "Substance Container Closure System"
},
{
"code" : "32S70",
"display" : "Substance Stability"
},
{
"code" : "32S71",
"display" : "Substance Stability Summary and Conclusions"
},
{
"code" : "32S72",
"display" : "Substance Postapproval Stability Protocol and Stability Commitment"
},
{
"code" : "32S73",
"display" : "Substance Stability Data"
},
{
"code" : "32P10",
"display" : "Product Description and Composition of the Drug Product"
},
{
"code" : "32P11",
"display" : "Product Description"
},
{
"code" : "32P12",
"display" : "Product Composition"
},
{
"code" : "32P13",
"display" : "Product Container Closure Description"
},
{
"code" : "32P20",
"display" : "Product Pharmaceutical Development"
},
{
"code" : "32P21",
"display" : "Product Components of the Drug Product"
},
{
"code" : "32P22",
"display" : "Product Drug Product"
},
{
"code" : "32P23",
"display" : "Product Manufacturing Process Development"
},
{
"code" : "32P24",
"display" : "Product Container Closure System"
},
{
"code" : "32P25",
"display" : "Product Microbiological Attributes"
},
{
"code" : "32P26",
"display" : "Product Compatibility"
},
{
"code" : "32P30",
"display" : "Product Manufacture"
},
{
"code" : "32P31",
"display" : "Product Manufacturers"
},
{
"code" : "32P32",
"display" : "Product Batch Formula"
},
{
"code" : "32P33",
"display" : "Product Description of Manufacturing Process and Process Controls"
},
{
"code" : "32P34",
"display" : "Product Controls of Critical Steps and Intermediates"
},
{
"code" : "32P35",
"display" : "Product Process Validation and/or Evaluation"
},
{
"code" : "32P40",
"display" : "Product Control of Excipients"
},
{
"code" : "32P41",
"display" : "Excipients Specification"
},
{
"code" : "32P42",
"display" : "Product Analytical Procedures"
},
{
"code" : "32P43",
"display" : "Product Validation of Analytical Procedures"
},
{
"code" : "32P44",
"display" : "Product Justification of Specifications"
},
{
"code" : "32P45",
"display" : "Product Excipients of Human or Animal Origin"
},
{
"code" : "32P46",
"display" : "Product Novel Excipients"
},
{
"code" : "32P50",
"display" : "Product name dosage form"
},
{
"code" : "32P51",
"display" : "Product Specification"
},
{
"code" : "32P52",
"display" : "Product Analytical Procedures"
},
{
"code" : "32P53",
"display" : "Product Validation of Analytical Procedures"
},
{
"code" : "32P54",
"display" : "Product Batch Analyses"
},
{
"code" : "32P55",
"display" : "Product Characterization of Impurities"
},
{
"code" : "32P56",
"display" : "Product Justification of Specifications"
},
{
"code" : "32P60",
"display" : "Product Reference Standards or Materials"
},
{
"code" : "32P70",
"display" : "Product Container Closure System"
},
{
"code" : "32P80",
"display" : "Product Stability"
},
{
"code" : "32P81",
"display" : "Product Stability Summary and Conclusion"
},
{
"code" : "32P82",
"display" : "Product Postapproval Stability Protocol and Stability Commitment"
},
{
"code" : "32P83",
"display" : "Product Stability Data"
},
{
"code" : "SP4151",
"display" : "Quality Specification"
},
{
"code" : "SP4454",
"display" : "Batch Analyses"
},
{
"code" : "SP7383",
"display" : "Stability Data"
},
{
"code" : "SP7181",
"display" : "Stability Summary and Conclusion"
}
]
}
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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