Error | ValueSet.version | Values for version differ: '1.0.0-ballot' vs '1.0.0' |
Information | ValueSet.date | Values for date differ: '2024-04-08T17:51:06+00:00' vs '2024-12-11T14:20:21+00:00' |
Error | ValueSet.compose.include[0] | Code ich_3.2.s added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.1 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.2 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.2.1 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.2.2 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.2.3 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.2.4 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.2.5 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.2.6 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.3 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.3.1 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.3.2 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.4 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.4.1 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.4.2 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.4.3 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.4.4 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.4.5 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.5 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.6 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.7 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.7.1 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.7.2 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.s.7.3 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.1 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.2 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.2.1 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.2.2 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.2.3 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.2.4 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.2.5 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.2.6 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.3 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.3.1 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.3.2 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.3.3 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.3.4 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.3.5 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.4 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.4.1 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.4.2 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.4.3 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.4.4 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.4.5 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.4.6 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.5 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.5.1 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.5.2 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.5.3 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.5.4 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.5.5 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.5.6 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.6 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.7 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.8 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.8.1 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.8.2 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.p.8.3 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.a added |
Error | ValueSet.compose.include[0] | Code ich_3.2.a.1 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.a.2 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.a.3 added |
Error | ValueSet.compose.include[0] | Code ich_3.2.r added |
Error | ValueSet.compose.include[0] | Code ich_3.3 added |
Name | Value | Comments | |
---|---|---|---|
compose.inactive | |||
compose.lockedDate | |||
copyright | |||
date | 2024-04-08T17:51:06+00:00 | 2024-12-11T14:20:21+00:00 |
|
description | Value set of all codes in Code system PQCMC Comp Section Types for bindings that require a value set instead of the code system. | Value set of all codes in Code system PQCMC Comp Section Types. |
|
experimental | false | ||
immutable | |||
jurisdiction | |||
jurisdiction[0] | urn:iso:std:iso:3166#US | ||
name | CmcCompSectionTypesVS | ||
publisher | HL7 International / Biomedical Research and Regulation | ||
purpose | |||
status | active | ||
title | eCTD sections Terminology | ||
url | http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs | ||
version | 1.0.0-ballot | 1.0.0 |
|
Item | Property | Value | Comments | ||
---|---|---|---|---|---|
include | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use | |||
Concept | ich_3.2.s | Version: Drug Substance |
| ||
Concept | ich_3.2.s.1 | Version: General Information |
| ||
Concept | ich_3.2.s.2 | Version: Manufacture |
| ||
Concept | ich_3.2.s.2.1 | Version: Manufacturers |
| ||
Concept | ich_3.2.s.2.2 | Version: Description of Manufacturing Process and Process Controls |
| ||
Concept | ich_3.2.s.2.3 | Version: Control of Materials |
| ||
Concept | ich_3.2.s.2.4 | Version: Controls of Critical Steps and Intermediates |
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Concept | ich_3.2.s.2.5 | Version: Process Validation and/or Evaluation |
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Concept | ich_3.2.s.2.6 | Version: Manufacturing Process Development |
| ||
Concept | ich_3.2.s.3 | Version: Characterisation |
| ||
Concept | ich_3.2.s.3.1 | Version: Elucidation of Structure and other Characteristics |
| ||
Concept | ich_3.2.s.3.2 | Version: Impurities |
| ||
Concept | ich_3.2.s.4 | Version: Control of Drug Substance |
| ||
Concept | ich_3.2.s.4.1 | Version: Specification |
| ||
Concept | ich_3.2.s.4.2 | Version: Analytical Procedures |
| ||
Concept | ich_3.2.s.4.3 | Version: Validation of Analytical Procedures |
| ||
Concept | ich_3.2.s.4.4 | Version: Batch Analyses |
| ||
Concept | ich_3.2.s.4.5 | Version: Justification of Specification |
| ||
Concept | ich_3.2.s.5 | Version: Reference Standards or Materials |
| ||
Concept | ich_3.2.s.6 | Version: Container Closure System |
| ||
Concept | ich_3.2.s.7 | Version: Stability |
| ||
Concept | ich_3.2.s.7.1 | Version: Stability Summary and Conclusions |
| ||
Concept | ich_3.2.s.7.2 | Version: Postapproval Stability Protocol and Stability Commitment |
| ||
Concept | ich_3.2.s.7.3 | Version: Stability Data |
| ||
Concept | ich_3.2.p | Version: Drug Product |
| ||
Concept | ich_3.2.p.1 | Version: Description and Composition of the Drug Product |
| ||
Concept | ich_3.2.p.2 | Version: Pharmaceutical Development |
| ||
Concept | ich_3.2.p.2.1 | Version: Components of the Drug Product |
| ||
Concept | ich_3.2.p.2.2 | Version: Drug Product |
| ||
Concept | ich_3.2.p.2.3 | Version: Manufacturing Process Development |
| ||
Concept | ich_3.2.p.2.4 | Version: Container Closure System |
| ||
Concept | ich_3.2.p.2.5 | Version: Microbiological Attributes |
| ||
Concept | ich_3.2.p.2.6 | Version: Compatibility |
| ||
Concept | ich_3.2.p.3 | Version: Manufacture |
| ||
Concept | ich_3.2.p.3.1 | Version: Manufacturer(s) |
| ||
Concept | ich_3.2.p.3.2 | Version: Batch Formula |
| ||
Concept | ich_3.2.p.3.3 | Version: Description of Manufacturing Process and Process Controls |
| ||
Concept | ich_3.2.p.3.4 | Version: Controls of Critical Steps and Intermediates |
| ||
Concept | ich_3.2.p.3.5 | Version: Process Validation and/or Evaluation |
| ||
Concept | ich_3.2.p.4 | Version: Control of Excipients |
| ||
Concept | ich_3.2.p.4.1 | Version: Specification |
| ||
Concept | ich_3.2.p.4.2 | Version: Analytical Procedures |
| ||
Concept | ich_3.2.p.4.3 | Version: Validation of Analytical Procedures |
| ||
Concept | ich_3.2.p.4.4 | Version: Justification of Specifications |
| ||
Concept | ich_3.2.p.4.5 | Version: Excipients of Human or Animal Origin |
| ||
Concept | ich_3.2.p.4.6 | Version: Novel Excipients |
| ||
Concept | ich_3.2.p.5 | Version: Control of Drug Product |
| ||
Concept | ich_3.2.p.5.1 | Version: Specification(s) |
| ||
Concept | ich_3.2.p.5.2 | Version: Analytical Procedures |
| ||
Concept | ich_3.2.p.5.3 | Version: Validation of Analytical Procedures |
| ||
Concept | ich_3.2.p.5.4 | Version: Batch Analyses |
| ||
Concept | ich_3.2.p.5.5 | Version: Characterisation of Impurities |
| ||
Concept | ich_3.2.p.5.6 | Version: Justification of Specifications |
| ||
Concept | ich_3.2.p.6 | Version: Reference Standards or Materials |
| ||
Concept | ich_3.2.p.7 | Version: Container Closure System |
| ||
Concept | ich_3.2.p.8 | Version: Stability |
| ||
Concept | ich_3.2.p.8.1 | Version: Stability Summary and Conclusion |
| ||
Concept | ich_3.2.p.8.2 | Version: Postapproval Stability Protocol and Stability Commitment |
| ||
Concept | ich_3.2.p.8.3 | Version: Stability Data |
| ||
Concept | ich_3.2.a | Version: Appendices |
| ||
Concept | ich_3.2.a.1 | Version: Facilities And Equipment |
| ||
Concept | ich_3.2.a.2 | Version: Adventitious Agents Safety Evaluation |
| ||
Concept | ich_3.2.a.3 | Version: Excipients |
| ||
Concept | ich_3.2.r | Version: Regional Information |
| ||
Concept | ich_3.3 | Version: Literature References |
|
Unable to generate expansion - see errors