Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2
This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v2.0.0: STU2) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions
| Page standards status: Trial-use | Maturity Level: 2 |
{
"resourceType" : "ValueSet",
"id" : "cmc-comp-section-types-vs",
"text" : {
"status" : "generated",
"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><ul><li>Include these codes as defined in <a href=\"http://terminology.hl7.org/6.4.0/CodeSystem-ICHContextOfUse.html\"><code>http://terminology.hl7.org/CodeSystem/ICHContextOfUse</code></a><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>m3.2.s drug substance</td></tr><tr><td>ich_3.2.s.1</td><td>m3.2.s.1 general information</td></tr><tr><td>ich_3.2.s.2</td><td>m3.2.s.2 manufacture</td></tr><tr><td>ich_3.2.s.2.1</td><td>m3.2.s.2.1 manufacturer(s)</td></tr><tr><td>ich_3.2.s.2.2</td><td>m3.2.s.2.2 description of manufacturing process and process controls</td></tr><tr><td>ich_3.2.s.2.3</td><td>m3.2.s.2.3 control of materials</td></tr><tr><td>ich_3.2.s.2.4</td><td>m3.2.s.2.4 controls of critical steps and intermediates</td></tr><tr><td>ich_3.2.s.2.5</td><td>m3.2.s.2.5 process validation and/or evaluation</td></tr><tr><td>ich_3.2.s.2.6</td><td>m3.2.s.2.6 manufacturing process development</td></tr><tr><td>ich_3.2.s.3</td><td>m3.2.s.3 characterisation</td></tr><tr><td>ich_3.2.s.3.1</td><td>m3.2.s.3.1 elucidation of structure and other characteristics</td></tr><tr><td>ich_3.2.s.3.2</td><td>m3.2.s.3.2 impurities</td></tr><tr><td>ich_3.2.s.4</td><td>m3.2.s.4 control of drug substance</td></tr><tr><td>ich_3.2.s.4.1</td><td>m3.2.s.4.1 specification</td></tr><tr><td>ich_3.2.s.4.2</td><td>m3.2.s.4.2 analytical procedures</td></tr><tr><td>ich_3.2.s.4.3</td><td>m3.2.s.4.3 validation of analytical procedures</td></tr><tr><td>ich_3.2.s.4.4</td><td>m3.2.s.4.4 batch analyses</td></tr><tr><td>ich_3.2.s.4.5</td><td>m3.2.s.4.5 justification of specification</td></tr><tr><td>ich_3.2.s.5</td><td>m3.2.s.5 reference standards or materials</td></tr><tr><td>ich_3.2.s.6</td><td>m3.2.s.6 container closure system</td></tr><tr><td>ich_3.2.s.7</td><td>m3.2.s.7 stability</td></tr><tr><td>ich_3.2.s.7.1</td><td>m3.2.s.7.1 stability summary and conclusions</td></tr><tr><td>ich_3.2.s.7.2</td><td>m3.2.s.7.2 post-approval stability protocol and stability commitment</td></tr><tr><td>ich_3.2.s.7.3</td><td>m3.2.s.7.3 stability data</td></tr><tr><td>ich_3.2.p</td><td>m3.2.p drug product</td></tr><tr><td>ich_3.2.p.1</td><td>m3.2.p.1 description and composition of the drug product</td></tr><tr><td>ich_3.2.p.2</td><td>m3.2.p.2 pharmaceutical development</td></tr><tr><td>ich_3.2.p.2.1</td><td>m3.2.p.2.1 components of the drug product</td></tr><tr><td>ich_3.2.p.2.2</td><td>m3.2.p.2.2 drug product</td></tr><tr><td>ich_3.2.p.2.3</td><td>m3.2.p.2.3 manufacturing process development</td></tr><tr><td>ich_3.2.p.2.4</td><td>m3.2.p.2.4 container closure system</td></tr><tr><td>ich_3.2.p.2.5</td><td>m3.2.p.2.5 microbiological attributes</td></tr><tr><td>ich_3.2.p.2.6</td><td>m3.2.p.2.6 compatibility</td></tr><tr><td>ich_3.2.p.3</td><td>m3.2.p.3 manufacture</td></tr><tr><td>ich_3.2.p.3.1</td><td>m3.2.p.3.1 manufacturer(s)</td></tr><tr><td>ich_3.2.p.3.2</td><td>m3.2.p.3.2 batch formula</td></tr><tr><td>ich_3.2.p.3.3</td><td>m3.2.p.3.3 description of manufacturing process and process controls</td></tr><tr><td>ich_3.2.p.3.4</td><td>m3.2.p.3.4 controls of critical steps and intermediates</td></tr><tr><td>ich_3.2.p.3.5</td><td>m3.2.p.3.5 process validation and/or evaluation</td></tr><tr><td>ich_3.2.p.4</td><td>m3.2.p.4 control of excipients</td></tr><tr><td>ich_3.2.p.4.1</td><td>m3.2.p.4.1 specifications</td></tr><tr><td>ich_3.2.p.4.2</td><td>m3.2.p.4.2 analytical procedures</td></tr><tr><td>ich_3.2.p.4.3</td><td>m3.2.p.4.3 validation of analytical procedures</td></tr><tr><td>ich_3.2.p.4.4</td><td>m3.2.p.4.4 justification of specifications</td></tr><tr><td>ich_3.2.p.4.5</td><td>m3.2.p.4.5 excipients of human or animal origin</td></tr><tr><td>ich_3.2.p.4.6</td><td>m3.2.p.4.6 novel excipients</td></tr><tr><td>ich_3.2.p.5</td><td>m3.2.p.5 control of drug product</td></tr><tr><td>ich_3.2.p.5.1</td><td>m3.2.p.5.1 specification(s)</td></tr><tr><td>ich_3.2.p.5.2</td><td>m3.2.p.5.2 analytical procedures</td></tr><tr><td>ich_3.2.p.5.3</td><td>m3.2.p.5.3 validation of analytical procedures</td></tr><tr><td>ich_3.2.p.5.4</td><td>m3.2.p.5.4 batch analyses</td></tr><tr><td>ich_3.2.p.5.5</td><td>m3.2.p.5.5 characterisation of impurities</td></tr><tr><td>ich_3.2.p.5.6</td><td>m3.2.p.5.6 justification of specifications</td></tr><tr><td>ich_3.2.p.6</td><td>m3.2.p.6 reference standards or materials</td></tr><tr><td>ich_3.2.p.7</td><td>m3.2.p.7 container closure system</td></tr><tr><td>ich_3.2.p.8</td><td>m3.2.p.8 stability</td></tr><tr><td>ich_3.2.p.8.1</td><td>m3.2.p.8.1 stability summary and conclusion</td></tr><tr><td>ich_3.2.p.8.2</td><td>m3.2.p.8.2 post-approval stability protocol and stability commitment</td></tr><tr><td>ich_3.2.p.8.3</td><td>m3.2.p.8.3 stability data</td></tr><tr><td>ich_3.2.a</td><td>m3.2.a appendices</td></tr><tr><td>ich_3.2.a.1</td><td>m3.2.a.1 facilities and equipment</td></tr><tr><td>ich_3.2.a.2</td><td>m3.2.a.2 adventitious agents safety evaluation</td></tr><tr><td>ich_3.2.a.3</td><td>m3.2.a.3 excipients</td></tr><tr><td>ich_3.2.r</td><td>m3.2 r regional information</td></tr><tr><td>ich_3.3</td><td>m3.3 literature references</td></tr></table></li></ul></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger" : 2,
"_valueInteger" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical" : "http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"
}
]
}
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "trial-use",
"_valueCode" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical" : "http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"
}
]
}
}
],
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs",
"identifier" : [
{
"system" : "urn:ietf:rfc:3986",
"value" : "urn:oid:2.16.840.1.113883.4.642.40.36.48.2"
}
],
"version" : "2.0.0",
"name" : "CmcCompSectionTypesVS",
"title" : "eCTD sections Terminology",
"status" : "active",
"experimental" : false,
"date" : "2025-07-08T07:43:10+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" : "Value set of all codes in Code system PQCMC Comp Section Types.",
"jurisdiction" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "US",
"display" : "United States of America"
}
]
}
],
"compose" : {
"include" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/ICHContextOfUse",
"concept" : [
{
"code" : "ich_3.2.s",
"display" : "m3.2.s drug substance"
},
{
"code" : "ich_3.2.s.1",
"display" : "m3.2.s.1 general information"
},
{
"code" : "ich_3.2.s.2",
"display" : "m3.2.s.2 manufacture"
},
{
"code" : "ich_3.2.s.2.1",
"display" : "m3.2.s.2.1 manufacturer(s)"
},
{
"code" : "ich_3.2.s.2.2",
"display" : "m3.2.s.2.2 description of manufacturing process and process controls"
},
{
"code" : "ich_3.2.s.2.3",
"display" : "m3.2.s.2.3 control of materials"
},
{
"code" : "ich_3.2.s.2.4",
"display" : "m3.2.s.2.4 controls of critical steps and intermediates"
},
{
"code" : "ich_3.2.s.2.5",
"display" : "m3.2.s.2.5 process validation and/or evaluation"
},
{
"code" : "ich_3.2.s.2.6",
"display" : "m3.2.s.2.6 manufacturing process development"
},
{
"code" : "ich_3.2.s.3",
"display" : "m3.2.s.3 characterisation"
},
{
"code" : "ich_3.2.s.3.1",
"display" : "m3.2.s.3.1 elucidation of structure and other characteristics"
},
{
"code" : "ich_3.2.s.3.2",
"display" : "m3.2.s.3.2 impurities"
},
{
"code" : "ich_3.2.s.4",
"display" : "m3.2.s.4 control of drug substance"
},
{
"code" : "ich_3.2.s.4.1",
"display" : "m3.2.s.4.1 specification"
},
{
"code" : "ich_3.2.s.4.2",
"display" : "m3.2.s.4.2 analytical procedures"
},
{
"code" : "ich_3.2.s.4.3",
"display" : "m3.2.s.4.3 validation of analytical procedures"
},
{
"code" : "ich_3.2.s.4.4",
"display" : "m3.2.s.4.4 batch analyses"
},
{
"code" : "ich_3.2.s.4.5",
"display" : "m3.2.s.4.5 justification of specification"
},
{
"code" : "ich_3.2.s.5",
"display" : "m3.2.s.5 reference standards or materials"
},
{
"code" : "ich_3.2.s.6",
"display" : "m3.2.s.6 container closure system"
},
{
"code" : "ich_3.2.s.7",
"display" : "m3.2.s.7 stability"
},
{
"code" : "ich_3.2.s.7.1",
"display" : "m3.2.s.7.1 stability summary and conclusions"
},
{
"code" : "ich_3.2.s.7.2",
"display" : "m3.2.s.7.2 post-approval stability protocol and stability commitment"
},
{
"code" : "ich_3.2.s.7.3",
"display" : "m3.2.s.7.3 stability data"
},
{
"code" : "ich_3.2.p",
"display" : "m3.2.p drug product"
},
{
"code" : "ich_3.2.p.1",
"display" : "m3.2.p.1 description and composition of the drug product"
},
{
"code" : "ich_3.2.p.2",
"display" : "m3.2.p.2 pharmaceutical development"
},
{
"code" : "ich_3.2.p.2.1",
"display" : "m3.2.p.2.1 components of the drug product"
},
{
"code" : "ich_3.2.p.2.2",
"display" : "m3.2.p.2.2 drug product"
},
{
"code" : "ich_3.2.p.2.3",
"display" : "m3.2.p.2.3 manufacturing process development"
},
{
"code" : "ich_3.2.p.2.4",
"display" : "m3.2.p.2.4 container closure system"
},
{
"code" : "ich_3.2.p.2.5",
"display" : "m3.2.p.2.5 microbiological attributes"
},
{
"code" : "ich_3.2.p.2.6",
"display" : "m3.2.p.2.6 compatibility"
},
{
"code" : "ich_3.2.p.3",
"display" : "m3.2.p.3 manufacture"
},
{
"code" : "ich_3.2.p.3.1",
"display" : "m3.2.p.3.1 manufacturer(s)"
},
{
"code" : "ich_3.2.p.3.2",
"display" : "m3.2.p.3.2 batch formula"
},
{
"code" : "ich_3.2.p.3.3",
"display" : "m3.2.p.3.3 description of manufacturing process and process controls"
},
{
"code" : "ich_3.2.p.3.4",
"display" : "m3.2.p.3.4 controls of critical steps and intermediates"
},
{
"code" : "ich_3.2.p.3.5",
"display" : "m3.2.p.3.5 process validation and/or evaluation"
},
{
"code" : "ich_3.2.p.4",
"display" : "m3.2.p.4 control of excipients"
},
{
"code" : "ich_3.2.p.4.1",
"display" : "m3.2.p.4.1 specifications"
},
{
"code" : "ich_3.2.p.4.2",
"display" : "m3.2.p.4.2 analytical procedures"
},
{
"code" : "ich_3.2.p.4.3",
"display" : "m3.2.p.4.3 validation of analytical procedures"
},
{
"code" : "ich_3.2.p.4.4",
"display" : "m3.2.p.4.4 justification of specifications"
},
{
"code" : "ich_3.2.p.4.5",
"display" : "m3.2.p.4.5 excipients of human or animal origin"
},
{
"code" : "ich_3.2.p.4.6",
"display" : "m3.2.p.4.6 novel excipients"
},
{
"code" : "ich_3.2.p.5",
"display" : "m3.2.p.5 control of drug product"
},
{
"code" : "ich_3.2.p.5.1",
"display" : "m3.2.p.5.1 specification(s)"
},
{
"code" : "ich_3.2.p.5.2",
"display" : "m3.2.p.5.2 analytical procedures"
},
{
"code" : "ich_3.2.p.5.3",
"display" : "m3.2.p.5.3 validation of analytical procedures"
},
{
"code" : "ich_3.2.p.5.4",
"display" : "m3.2.p.5.4 batch analyses"
},
{
"code" : "ich_3.2.p.5.5",
"display" : "m3.2.p.5.5 characterisation of impurities"
},
{
"code" : "ich_3.2.p.5.6",
"display" : "m3.2.p.5.6 justification of specifications"
},
{
"code" : "ich_3.2.p.6",
"display" : "m3.2.p.6 reference standards or materials"
},
{
"code" : "ich_3.2.p.7",
"display" : "m3.2.p.7 container closure system"
},
{
"code" : "ich_3.2.p.8",
"display" : "m3.2.p.8 stability"
},
{
"code" : "ich_3.2.p.8.1",
"display" : "m3.2.p.8.1 stability summary and conclusion"
},
{
"code" : "ich_3.2.p.8.2",
"display" : "m3.2.p.8.2 post-approval stability protocol and stability commitment"
},
{
"code" : "ich_3.2.p.8.3",
"display" : "m3.2.p.8.3 stability data"
},
{
"code" : "ich_3.2.a",
"display" : "m3.2.a appendices"
},
{
"code" : "ich_3.2.a.1",
"display" : "m3.2.a.1 facilities and equipment"
},
{
"code" : "ich_3.2.a.2",
"display" : "m3.2.a.2 adventitious agents safety evaluation"
},
{
"code" : "ich_3.2.a.3",
"display" : "m3.2.a.3 excipients"
},
{
"code" : "ich_3.2.r",
"display" : "m3.2 r regional information"
},
{
"code" : "ich_3.3",
"display" : "m3.3 literature references"
}
]
}
]
}
}
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0 based on FHIR 5.0.0. Generated 2025-07-08
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change