| Package | hl7.fhir.us.pq-cmc-fda |
| Type | ValueSet |
| Id | cmc-comp-section-types-vs |
| FHIR Version | R5 |
| Source | http://hl7.org/fhir/us/pq-cmc-fda/https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda/ValueSet-cmc-comp-section-types-vs.html |
| URL | http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs |
| Version | 2.0.0 |
| Status | active |
| Date | 2025-07-03T13:07:08+00:00 |
| Name | CmcCompSectionTypesVS |
| Title | eCTD sections Terminology |
| Realm | us |
| Authority | hl7 |
| Description | Value set of all codes in Code system PQCMC Comp Section Types. |
No resources found
| CodeSystem | |
| ICHContextOfUse | ICH Context of Use |
Note: links and images are rebased to the (stated) source
Generated Narrative: ValueSet cmc-comp-section-types-vs
FHIRhttp://terminology.hl7.org/CodeSystem/ICHContextOfUse| Code | Display |
| ich_3.2.s | m3.2.s drug substance |
| ich_3.2.s.1 | m3.2.s.1 general information |
| ich_3.2.s.2 | m3.2.s.2 manufacture |
| ich_3.2.s.2.1 | m3.2.s.2.1 manufacturer(s) |
| ich_3.2.s.2.2 | m3.2.s.2.2 description of manufacturing process and process controls |
| ich_3.2.s.2.3 | m3.2.s.2.3 control of materials |
| ich_3.2.s.2.4 | m3.2.s.2.4 controls of critical steps and intermediates |
| ich_3.2.s.2.5 | m3.2.s.2.5 process validation and/or evaluation |
| ich_3.2.s.2.6 | m3.2.s.2.6 manufacturing process development |
| ich_3.2.s.3 | m3.2.s.3 characterisation |
| ich_3.2.s.3.1 | m3.2.s.3.1 elucidation of structure and other characteristics |
| ich_3.2.s.3.2 | m3.2.s.3.2 impurities |
| ich_3.2.s.4 | m3.2.s.4 control of drug substance |
| ich_3.2.s.4.1 | m3.2.s.4.1 specification |
| ich_3.2.s.4.2 | m3.2.s.4.2 analytical procedures |
| ich_3.2.s.4.3 | m3.2.s.4.3 validation of analytical procedures |
| ich_3.2.s.4.4 | m3.2.s.4.4 batch analyses |
| ich_3.2.s.4.5 | m3.2.s.4.5 justification of specification |
| ich_3.2.s.5 | m3.2.s.5 reference standards or materials |
| ich_3.2.s.6 | m3.2.s.6 container closure system |
| ich_3.2.s.7 | m3.2.s.7 stability |
| ich_3.2.s.7.1 | m3.2.s.7.1 stability summary and conclusions |
| ich_3.2.s.7.2 | m3.2.s.7.2 post-approval stability protocol and stability commitment |
| ich_3.2.s.7.3 | m3.2.s.7.3 stability data |
| ich_3.2.p | m3.2.p drug product |
| ich_3.2.p.1 | m3.2.p.1 description and composition of the drug product |
| ich_3.2.p.2 | m3.2.p.2 pharmaceutical development |
| ich_3.2.p.2.1 | m3.2.p.2.1 components of the drug product |
| ich_3.2.p.2.2 | m3.2.p.2.2 drug product |
| ich_3.2.p.2.3 | m3.2.p.2.3 manufacturing process development |
| ich_3.2.p.2.4 | m3.2.p.2.4 container closure system |
| ich_3.2.p.2.5 | m3.2.p.2.5 microbiological attributes |
| ich_3.2.p.2.6 | m3.2.p.2.6 compatibility |
| ich_3.2.p.3 | m3.2.p.3 manufacture |
| ich_3.2.p.3.1 | m3.2.p.3.1 manufacturer(s) |
| ich_3.2.p.3.2 | m3.2.p.3.2 batch formula |
| ich_3.2.p.3.3 | m3.2.p.3.3 description of manufacturing process and process controls |
| ich_3.2.p.3.4 | m3.2.p.3.4 controls of critical steps and intermediates |
| ich_3.2.p.3.5 | m3.2.p.3.5 process validation and/or evaluation |
| ich_3.2.p.4 | m3.2.p.4 control of excipients |
| ich_3.2.p.4.1 | m3.2.p.4.1 specifications |
| ich_3.2.p.4.2 | m3.2.p.4.2 analytical procedures |
| ich_3.2.p.4.3 | m3.2.p.4.3 validation of analytical procedures |
| ich_3.2.p.4.4 | m3.2.p.4.4 justification of specifications |
| ich_3.2.p.4.5 | m3.2.p.4.5 excipients of human or animal origin |
| ich_3.2.p.4.6 | m3.2.p.4.6 novel excipients |
| ich_3.2.p.5 | m3.2.p.5 control of drug product |
| ich_3.2.p.5.1 | m3.2.p.5.1 specification(s) |
| ich_3.2.p.5.2 | m3.2.p.5.2 analytical procedures |
| ich_3.2.p.5.3 | m3.2.p.5.3 validation of analytical procedures |
| ich_3.2.p.5.4 | m3.2.p.5.4 batch analyses |
| ich_3.2.p.5.5 | m3.2.p.5.5 characterisation of impurities |
| ich_3.2.p.5.6 | m3.2.p.5.6 justification of specifications |
| ich_3.2.p.6 | m3.2.p.6 reference standards or materials |
| ich_3.2.p.7 | m3.2.p.7 container closure system |
| ich_3.2.p.8 | m3.2.p.8 stability |
| ich_3.2.p.8.1 | m3.2.p.8.1 stability summary and conclusion |
| ich_3.2.p.8.2 | m3.2.p.8.2 post-approval stability protocol and stability commitment |
| ich_3.2.p.8.3 | m3.2.p.8.3 stability data |
| ich_3.2.a | m3.2.a appendices |
| ich_3.2.a.1 | m3.2.a.1 facilities and equipment |
| ich_3.2.a.2 | m3.2.a.2 adventitious agents safety evaluation |
| ich_3.2.a.3 | m3.2.a.3 excipients |
| ich_3.2.r | m3.2 r regional information |
| ich_3.3 | m3.3 literature references |
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"code": "ich_3.2.s.1",
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"display": "m3.2.s.2 manufacture"
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"display": "m3.2.s.2.1 manufacturer(s)"
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"code": "ich_3.2.s.2.2",
"display": "m3.2.s.2.2 description of manufacturing process and process controls"
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"code": "ich_3.2.s.2.3",
"display": "m3.2.s.2.3 control of materials"
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"code": "ich_3.2.s.2.4",
"display": "m3.2.s.2.4 controls of critical steps and intermediates"
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"display": "m3.2.s.2.5 process validation and/or evaluation"
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"display": "m3.2.s.2.6 manufacturing process development"
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"display": "m3.2.s.3 characterisation"
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"display": "m3.2.s.3.1 elucidation of structure and other characteristics"
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"code": "ich_3.2.s.3.2",
"display": "m3.2.s.3.2 impurities"
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"code": "ich_3.2.s.4",
"display": "m3.2.s.4 control of drug substance"
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"display": "m3.2.s.4.1 specification"
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"code": "ich_3.2.s.4.2",
"display": "m3.2.s.4.2 analytical procedures"
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"code": "ich_3.2.s.4.3",
"display": "m3.2.s.4.3 validation of analytical procedures"
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{
"code": "ich_3.2.s.4.4",
"display": "m3.2.s.4.4 batch analyses"
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{
"code": "ich_3.2.s.4.5",
"display": "m3.2.s.4.5 justification of specification"
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{
"code": "ich_3.2.s.5",
"display": "m3.2.s.5 reference standards or materials"
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{
"code": "ich_3.2.s.6",
"display": "m3.2.s.6 container closure system"
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{
"code": "ich_3.2.s.7",
"display": "m3.2.s.7 stability"
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{
"code": "ich_3.2.s.7.1",
"display": "m3.2.s.7.1 stability summary and conclusions"
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{
"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"
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{
"code": "ich_3.2.p.2.1",
"display": "m3.2.p.2.1 components of the drug product"
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{
"code": "ich_3.2.p.2.2",
"display": "m3.2.p.2.2 drug product"
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{
"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)"
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{
"code": "ich_3.2.p.5.2",
"display": "m3.2.p.5.2 analytical procedures"
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{
"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"
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{
"code": "ich_3.2.r",
"display": "m3.2 r regional information"
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{
"code": "ich_3.3",
"display": "m3.3 literature references"
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}