| Version 1.0.0-ballot |
Current Build |
Difference |
Union |
Intersection |
Notes |
| CodeSystems |
| PQ-CMC-FDA NCIt Hieararchy Supplement | Added | |
| PQ-CMC-FDA Temporary Codes | | Removed | |
| Product Name Types Code Types | | Removed | |
| Relationship Types Codes | | Removed | |
| Code System PQCMC Comp Section Types | | Removed | |
| Hierarchical Test Category Codes | | Removed | |
| ValueSets |
| Action Reason Code | Test Category Terminology | Comparison | Union | Intersection | 110 Breaking Changes, 1 Change, 9 Notes |
| Combined Dose Form | Pharmaceutical Dosage Form Terminology | Comparison | Union | Intersection | 169 Breaking Changes, 1 Change, 9 Notes |
| Condition/Problem/Diagnosis Codes | Test Usage Terminology | Comparison | Union | Intersection | 2 Breaking Changes, 1 Change, 12 Notes |
| Country ValueSet | GENC and ISO 3166 Intersection | Comparison | Union | Intersection | 3 Breaking Changes, 1 Change, 9 Notes |
| Manufactured Dose Form | Manufactured Dose Form Terminology | Comparison | Union | Intersection | 9 Breaking Changes, 1 Change, 9 Notes |
| Product Name Type | Product Name Types Terminology | Comparison | Union | Intersection | 4 Breaking Changes, 1 Change, 9 Notes |
| SNOMED CT Route Codes | Drug Route Of Administration Terminology | Comparison | Union | Intersection | 127 Breaking Changes, 1 Change, 9 Notes |
| Substance Grade | Quality Benchmark Terminology | Comparison | Union | Intersection | 7 Breaking Changes, 1 Change, 9 Notes |
| Substance Name Type | Substance Name Type | Comparison | Union | Intersection | 13 Breaking Changes, 1 Change, 8 Notes |
| Substance Representation Type | Representation Types | Comparison | Union | Intersection | 5 Breaking Changes, 1 Change, 9 Notes |
| Source Material Type | Source Type Terminology | Comparison | Union | Intersection | 9 Breaking Changes, 1 Change, 9 Notes |
| Capsule Shell Classification Terminology | Capsule Shell Classification Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| eCTD sections Terminology | Document Section Codes | Comparison | Union | Intersection | 59 Breaking Changes, 1 Change, 9 Notes |
| eCTD sections Terminology | eCTD sections Terminology | Comparison | Union | Intersection | 66 Breaking Changes, 0 Changes, 2 Notes |
| Product Name Types Terminology | Product Name Types Terminology | Comparison | Union | Intersection | 3 Breaking Changes, 0 Changes, 2 Notes |
| Relationship Types Terminology | | Removed | |
| Specification Section Type Terminology | Added | |
| Analytical Instrument Data File Types | Added | |
| Batch utilization Terminology | Added | |
| Chemical Structure Data File Type Terminology | Chemical Structure Data File Type Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Closure Type Terminology | Closure Type Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Coating Purpose Terminology | Coating Purpose Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Conformance to Criteria Terminology | | Removed | |
| Container Type Terminology | Container Type Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Drug Product Component Function Category Terminology | Drug Product Component Function Category Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Excipient Function Terminology | Excipient Function Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 51 Notes |
| GENC and ISO 3166 Intersection | Added | |
| Graphical File Types | Added | |
| Impurity Classification Terminology | Added | |
| Interpretation Code Terminology | | Removed | |
| Manufactured Dose Form Terminology | Manufactured Dose Form Terminology | Comparison | Union | Intersection | 8 Breaking Changes, 0 Changes, 3 Notes |
| Name Part Terminology | PQCMC Name Part Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Non-Percentage Units | Added | |
| Organization-Site Identifier Terminology | Identifier Type Codes | Comparison | Union | Intersection | 24 Breaking Changes, 0 Changes, 7 Notes |
| Organization-Site Identifier Terminology | Organization-Site Identifier Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Percentage Units | Added | |
| Code System PQCMC Product Characteristic | | Removed | |
| Ingredient Location Terminology | Ingredient Location Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Product Part Type Terminology | Product Part Type Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Quality Benchmark Terminology | Quality Benchmark Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Release Mechanism Terminology | Release Mechanism Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Release Profile Terminology | Release Profile Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Representation Types | Added | |
| Source Type Terminology | Source Type Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Specification Status Terminology | Specification Status Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Specification Type Terminology | Specification Type Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Strength Operator Terminology | | Removed | |
| Strength Type Terminology | Strength Type Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Structure Data Types | Added | |
| Substance Name Type | Substance Name Type | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Test Category Terminology | Test Category Terminology | Comparison | Union | Intersection | 109 Breaking Changes, 0 Changes, 1 Note |
| Test Method Origin Terminology | Test Method Origin Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Test Usage Terminology | Test Usage Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Units Of Measure Terminology | | Removed | |
| Units Of Measure | Added | |
| Drug Route Of Administration Terminology | Drug Route Of Administration Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Pharmaceutical Dosage Form Terminology | Pharmaceutical Dosage Form Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Substance Classification | Substance Classification | Comparison | Union | Intersection | 3 Breaking Changes, 0 Changes, 1 Note |
| StructureDefinitions |
| OperationOutcome | OperationOutcome | Failed | StructureDefinition is not for an profile - can't be compared (left: OperationOutcome) |
| ContainerClosure | Added | |
| Document Reference Attachment | Document Reference Attachment | Comparison | Union | Intersection | 1 Breaking Change, 1 Change, 24 Notes |
| CMC eCTD 32P10 Document | CMC eCTD 32P10 Document | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 19 Notes |
| CMC eCTD 32P32 Document | Added | |
| CMC eCTD 32P55 Document | Added | |
| CMC eCTD 32S10 Document | CMC eCTD 32S10 Document | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 19 Notes |
| CMC eCTD 32S23 Document | CMC eCTD 32S23 Document | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 19 Notes |
| CMC eCTD 32S3 Document | Added | |
| CMC eCTD SP4151 Document | CMC eCTD SP4151 Document | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 19 Notes |
| Basic Organization | Added | |
| Sponsor Organization | Basic Organization | Comparison | Union | Intersection | 2 Breaking Changes, 2 Changes, 13 Notes |
| Sponsor Organization | | Removed | |
| Text Only Codeable Concept | Added | |
| Content Percent | | Removed | |
| eCTD Product Description and Composition | eCTD Product Description and Composition | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 9 Notes |
| eCTD Batch Formula | Added | |
| eCTD Product Characterisation of Impurities Composition | Added | |
| eCTD Substance General Information | eCTD Substance General Information | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 9 Notes |
| eCTD Substance Control of Materials Composition | eCTD Substance Control of Materials Composition | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 9 Notes |
| eCTD Substance Characterisation | Added | |
| eCTD Specification Composition | eCTD Specification Composition | Comparison | Union | Intersection | 1 Breaking Change, 2 Changes, 11 Notes |
| Literal Coded Reference | Added | |
| Literal Reference | Added | |
| Manufacturing and/or Test Site Organization | Basic Organization | Comparison | Union | Intersection | 2 Breaking Changes, 2 Changes, 13 Notes |
| Manufacturing and/or Test Site Organization | | Removed | |
| Optional Denominator | | Removed | |
| Additional Information | Additional Information | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Amount Ratio | Added | |
| PqAddress | PqAddress | Comparison | Union | Intersection | 1 Breaking Change, 1 Change, 2 Notes |
| Container Closure | | Removed | |
| Hierarchical Level | Hierarchical Level | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Profile IG Version | | Removed | |
| Interpretation Code | | Removed | |
| Test Order | Stage Sequence Order | | Removed | |
| Product Batch Ingredient Extension | Added | |
| Product Batch Strength Textual Extension | Added | |
| Specification Status | Added | |
| Specification Type | | Removed | |
| Target Range | Added | |
| Analytical Instrument Data | Added | |
| PQCMC Attachment | Added | |
| Batch Formula Drug Product Identification | Added | |
| Component Substance | Component Substance | Comparison | Union | Intersection | 1 Breaking Change, 7 Changes, 46 Notes |
| Drug Product Component | Drug Product Component | Comparison | Union | Intersection | 2 Breaking Changes, 3 Changes, 14 Notes |
| Drug Product Batch Formula Ingredient | Added | |
| Drug Product Description | Drug Product Description | Comparison | Union | Intersection | 1 Breaking Change, 1 Change, 20 Notes |
| Drug Product Description | Drug Product Handle | Comparison | Union | Intersection | 2 Breaking Changes, 1 Change, 24 Notes |
| Drug Product Handle | Added | |
| Drug Substance Impurity | Added | |
| Drug Product Impurities | Added | |
| Drug Substance | Added | |
| Substance General Information | Substance General Information | Comparison | Union | Intersection | 1 Breaking Change, 6 Changes, 26 Notes |
| Drug Product Container Closure | | Removed | |
| Excipient Drug Substance | Excipient Drug Substance | Comparison | Union | Intersection | 1 Breaking Change, 1 Change, 41 Notes |
| Analysis Graphic | Added | |
| Graphic Reference | Added | |
| Attached Document (PDF) | Added | |
| Polymorphic Form | Polymorphic Form | Comparison | Union | Intersection | 1 Breaking Change, 4 Changes, 19 Notes |
| Drug Product Batch Formula | Added | |
| Manufactured Drug Product | Manufactured Drug Product | Comparison | Union | Intersection | 2 Breaking Changes, 3 Changes, 49 Notes |
| Quality Specification | Quality Specification | Comparison | Union | Intersection | 1 Breaking Change, 5 Changes, 48 Notes |
| Routine Drug Product | Drug Product Handle | Comparison | Union | Intersection | 2 Breaking Changes, 2 Changes, 22 Notes |
| Routine Drug Product | | Removed | |
| Routine Drug Substance | Drug Substance Handle | Comparison | Union | Intersection | 1 Breaking Change, 1 Change, 15 Notes |
| Structure Data | Added | |
| Structure Data Reference | Added | |
| Strength Extension | Strength Extension | Comparison | Union | Intersection | 3 Breaking Changes, 1 Change, 6 Notes |
| Supplier Organization | Basic Organization | Comparison | Union | Intersection | 2 Breaking Changes, 1 Change, 13 Notes |
| Supplier Organization | | Removed | |