ValueSet Comparison between http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs vs http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs

Messages

ErrorValueSet.versionValues for version differ: '1.0.0' vs '2.0.0-ballot'
InformationValueSet.dateValues for date differ: '2024-12-11T13:47:08+00:00' vs '2024-12-12T01:58:44+00:00'

Metadata

NameValueComments
.compose.inactive
    .compose.lockedDate
      .copyright
        .date2024-12-11T13:47:08+00:002024-12-12T01:58:44+00:00
        • Values Differ
        .descriptionValue set of all codes in Code system PQCMC Comp Section Types.
          .experimentalfalse
            .immutable
              .jurisdiction
                ..jurisdiction[0]urn:iso:std:iso:3166#US
                  .nameCmcCompSectionTypesVS
                    .publisherHL7 International / Biomedical Research and Regulation
                      .purpose
                        .statusactive
                          .titleeCTD sections Terminology
                            .urlhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs
                              .version1.0.02.0.0-ballot
                              • Values Differ

                              Definition

                              ItemPropertyValueComments
                              .includehttp://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use
                                ..Conceptich_3.2.sDrug Substance
                                  ..Conceptich_3.2.s.1General Information
                                    ..Conceptich_3.2.s.2Manufacture
                                      ..Conceptich_3.2.s.2.1Manufacturers
                                        ..Conceptich_3.2.s.2.2Description of Manufacturing Process and Process Controls
                                          ..Conceptich_3.2.s.2.3Control of Materials
                                            ..Conceptich_3.2.s.2.4Controls of Critical Steps and Intermediates
                                              ..Conceptich_3.2.s.2.5Process Validation and/or Evaluation
                                                ..Conceptich_3.2.s.2.6Manufacturing Process Development
                                                  ..Conceptich_3.2.s.3Characterisation
                                                    ..Conceptich_3.2.s.3.1Elucidation of Structure and other Characteristics
                                                      ..Conceptich_3.2.s.3.2Impurities
                                                        ..Conceptich_3.2.s.4Control of Drug Substance
                                                          ..Conceptich_3.2.s.4.1Specification
                                                            ..Conceptich_3.2.s.4.2Analytical Procedures
                                                              ..Conceptich_3.2.s.4.3Validation of Analytical Procedures
                                                                ..Conceptich_3.2.s.4.4Batch Analyses
                                                                  ..Conceptich_3.2.s.4.5Justification of Specification
                                                                    ..Conceptich_3.2.s.5Reference Standards or Materials
                                                                      ..Conceptich_3.2.s.6Container Closure System
                                                                        ..Conceptich_3.2.s.7Stability
                                                                          ..Conceptich_3.2.s.7.1Stability Summary and Conclusions
                                                                            ..Conceptich_3.2.s.7.2Postapproval Stability Protocol and Stability Commitment
                                                                              ..Conceptich_3.2.s.7.3Stability Data
                                                                                ..Conceptich_3.2.pDrug Product
                                                                                  ..Conceptich_3.2.p.1Description and Composition of the Drug Product
                                                                                    ..Conceptich_3.2.p.2Pharmaceutical Development
                                                                                      ..Conceptich_3.2.p.2.1Components of the Drug Product
                                                                                        ..Conceptich_3.2.p.2.2Drug Product
                                                                                          ..Conceptich_3.2.p.2.3Manufacturing Process Development
                                                                                            ..Conceptich_3.2.p.2.4Container Closure System
                                                                                              ..Conceptich_3.2.p.2.5Microbiological Attributes
                                                                                                ..Conceptich_3.2.p.2.6Compatibility
                                                                                                  ..Conceptich_3.2.p.3Manufacture
                                                                                                    ..Conceptich_3.2.p.3.1Manufacturer(s)
                                                                                                      ..Conceptich_3.2.p.3.2Batch Formula
                                                                                                        ..Conceptich_3.2.p.3.3Description of Manufacturing Process and Process Controls
                                                                                                          ..Conceptich_3.2.p.3.4Controls of Critical Steps and Intermediates
                                                                                                            ..Conceptich_3.2.p.3.5Process Validation and/or Evaluation
                                                                                                              ..Conceptich_3.2.p.4Control of Excipients
                                                                                                                ..Conceptich_3.2.p.4.1Specification
                                                                                                                  ..Conceptich_3.2.p.4.2Analytical Procedures
                                                                                                                    ..Conceptich_3.2.p.4.3Validation of Analytical Procedures
                                                                                                                      ..Conceptich_3.2.p.4.4Justification of Specifications
                                                                                                                        ..Conceptich_3.2.p.4.5Excipients of Human or Animal Origin
                                                                                                                          ..Conceptich_3.2.p.4.6Novel Excipients
                                                                                                                            ..Conceptich_3.2.p.5Control of Drug Product
                                                                                                                              ..Conceptich_3.2.p.5.1Specification(s)
                                                                                                                                ..Conceptich_3.2.p.5.2Analytical Procedures
                                                                                                                                  ..Conceptich_3.2.p.5.3Validation of Analytical Procedures
                                                                                                                                    ..Conceptich_3.2.p.5.4Batch Analyses
                                                                                                                                      ..Conceptich_3.2.p.5.5Characterisation of Impurities
                                                                                                                                        ..Conceptich_3.2.p.5.6Justification of Specifications
                                                                                                                                          ..Conceptich_3.2.p.6Reference Standards or Materials
                                                                                                                                            ..Conceptich_3.2.p.7Container Closure System
                                                                                                                                              ..Conceptich_3.2.p.8Stability
                                                                                                                                                ..Conceptich_3.2.p.8.1Stability Summary and Conclusion
                                                                                                                                                  ..Conceptich_3.2.p.8.2Postapproval Stability Protocol and Stability Commitment
                                                                                                                                                    ..Conceptich_3.2.p.8.3Stability Data
                                                                                                                                                      ..Conceptich_3.2.aAppendices
                                                                                                                                                        ..Conceptich_3.2.a.1Facilities And Equipment
                                                                                                                                                          ..Conceptich_3.2.a.2Adventitious Agents Safety Evaluation
                                                                                                                                                            ..Conceptich_3.2.a.3Excipients
                                                                                                                                                              ..Conceptich_3.2.rRegional Information
                                                                                                                                                                ..Conceptich_3.3Literature References

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