| Version 2.0.0-ballot |
Current Build |
Difference |
Union |
Intersection |
Notes |
| CodeSystems |
| PQ-CMC-FDA NCIt Hieararchy Supplement | PQ-CMC-FDA NCIt Hierarchy Supplement | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 3 Notes |
| ValueSets |
| Capsule Shell Classification Terminology | Capsule Shell Classification Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| eCTD sections Terminology | eCTD sections Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 66 Notes |
| Product Name Types Terminology | Product Name Types Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Specification Section Type Terminology | Specification Section Type Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 4 Notes |
| Analytical Instrument Data File Types | Analytical Instrument Data File Types | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Batch utilization Terminology | Batch utilization Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| 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 |
| 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, 1 Note |
| GENC and ISO 3166 Intersection | GENC and ISO 3166 Intersection | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 5 Notes |
| Graphical File Types | Graphical File Types | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 6 Notes |
| Impurity Classification Terminology | Impurity Classification Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Manufactured Dose Form Terminology | Manufactured Dose Form Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| PQCMC Name Part Terminology | PQCMC Name Part Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Non-Percentage Units | Non-Percentage Units | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Organization-Site Identifier Terminology | | Removed | |
| Percentage Units | Percentage Units | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| 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 | Representation Types | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Source Type Terminology | Source Type Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| 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 Type Terminology | Strength Type Terminology | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Structure Data Types | Structure Data Types | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Substance Name Type | Substance Name Type | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Test Category Terminology | Test Category Terminology | Comparison | Union | Intersection | 1 Breaking Change, 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 | Units Of Measure | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| 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 | 1 Breaking Change, 0 Changes, 1 Note |
| StructureDefinitions |
| OperationOutcome | OperationOutcome | Failed | StructureDefinition is not for an profile - can't be compared (left: OperationOutcome) |
| SimpleQuantity | SimpleQuantity | Comparison | Union | Intersection | 0 Breaking Changes, 0 Changes, 0 Notes |
| ContainerClosure | ContainerClosure | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Document Reference Attachment | Document Reference Attachment | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| CMC eCTD 32P10 Document | CMC eCTD 32P10 Document | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 2 Notes |
| CMC eCTD 32P32 Document | CMC eCTD 32P32 Document | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 1 Note |
| CMC eCTD 32P55 Document | CMC eCTD 32P55 Document | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 1 Note |
| CMC eCTD 32S10 Document | CMC eCTD 32S10 Document | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 2 Notes |
| CMC eCTD 32S23 Document | CMC eCTD 32S23 Document | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 2 Notes |
| CMC eCTD 32S3 Document | CMC eCTD 32S3 Document | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 2 Notes |
| CMC eCTD SP4151 Document | CMC eCTD SP4151 Document | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 2 Notes |
| Basic Organization | Basic Organization | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Text Only Codeable Concept | Text Only Codeable Concept | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| eCTD Product Description and Composition | eCTD Product Description and Composition | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| eCTD Batch Formula | eCTD Batch Formula | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| eCTD Product Characterisation of Impurities Composition | eCTD Product Characterisation of Impurities | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 3 Notes |
| eCTD Substance General Information | eCTD Substance General Information | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| eCTD Substance Control of Materials Composition | eCTD Substance Control of Materials | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| eCTD Substance Characterisation | eCTD Substance Characterisation | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| eCTD Specification Composition | eCTD Specification | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Literal Coded Reference | Literal Coded Reference | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Literal Reference | Literal Reference | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Additional Information | Additional Information | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Amount Ratio | Amount Ratio | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| PqAddress | PqAddress | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Hierarchical Level | Hierarchical Level | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Overage Extension | Added | |
| Product Batch Ingredient Extension | | Removed | |
| Product Batch Strength Textual Extension | Product Batch Strength Textual Extension | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Specification Status | Specification Status | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Target Range | Target Range | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Analytical Instrument Data | Analytical Instrument Data | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| PQCMC Attachment | PQCMC Attachment | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Batch Formula Drug Product Identification | Batch Formula Drug Product Identification | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Component Substance | Component Substance | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Drug Product Component | Drug Product Component | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Drug Product Batch Formula Ingredient | Drug Product Batch Formula Ingredient | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Drug Product Description | Drug Product Description | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Drug Product Handle | Drug Product Handle | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Drug Substance Impurity | Drug Substance Impurity | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Drug Product Impurities | Drug Product Impurities | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Drug Substance | Drug Substance | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Substance General Information | Substance General Information | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Excipient Drug Substance | Excipient Drug Substance | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Analysis Graphic | Analysis Graphic | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Graphic Reference | Graphic Reference | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Attached Document (PDF) | Attached Document (PDF) | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Polymorphic Form | Polymorphic Form | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Drug Product Batch Formula | Drug Product Batch Formula | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Manufactured Drug Product | Manufactured Drug Product | Comparison | Union | Intersection | 1 Breaking Change, 1 Change, 2 Notes |
| Quality Specification | Quality Specification | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Drug Substance Handle | Drug Substance Handle | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Structure Data | Structure Data | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Structure Data Reference | Structure Data Reference | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Strength Extension | Strength Type | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |