| Version 1.0.0-ballot |
Current Build |
Difference |
Union |
Intersection |
Notes |
| CodeSystems |
| CodeSystem - Batch Designation | | Removed | |
| CodeSystem - Characterization Step | | Removed | |
| CodeSystem - Closure Types | | Removed | |
| CodeSystem - Color | | Removed | |
| CodeSystem - Container Orientation | | Removed | |
| CodeSystem - Control Criticality | | Removed | |
| CodeSystem - Device Property | | Removed | |
| CodeSystem - Device Type | | Removed | |
| Device Type - example | Added | |
| CodeSystem - Diagram Type | | Removed | |
| CodeSystem - Equipment Class | | Removed | |
| CodeSystem - Goal Priority | | Removed | |
| Goal Priority - example | Added | |
| CodeSystem - Grade | | Removed | |
| CodeSystem - ICH M7 Classification | | Removed | |
| CodeSystem - Impurity Origin | | Removed | |
| CodeSystem - Impurity Type | | Removed | |
| CodeSystem - Ingredient Function | | Removed | |
| Example Local Codes - Drug | Added | |
| CodeSystem - Example Local Codes - Drug | | Removed | |
| CodeSystem - Manufactured Item Property | | Removed | |
| Manufactured Item Property - example | Added | |
| CodeSystem - Manufacturing Participant Role | | Removed | |
| CodeSystem - Manufacturing Step | | Removed | |
| CodeSystem - Manufacturing Step Scale | | Removed | |
| CodeSystem - Mutagenicity | | Removed | |
| CodeSystem - Mutagenicity Classification Type | | Removed | |
| CodeSystem - Package Property | | Removed | |
| CodeSystem - Plan Type | | Removed | |
| CodeSystem - Process Parameter | | Removed | |
| CodeSystem - Product Name Type | | Removed | |
| Product Name Type - example | Added | |
| CodeSystem - Product Site Utilization Type | | Removed | |
| CodeSystem - Qualified Value Criticality | | Removed | |
| CodeSystem - Report Type | | Removed | |
| CodeSystem - Specification Type | | Removed | |
| Specification Type - example | Added | |
| CodeSystem - Substance Property | | Removed | |
| Substance Property - example | Added | |
| CodeSystem - Substance Property Solubility | | Removed | |
| Substance Property Value - example | Added | |
| CodeSystem - Substance Property Type | | Removed | |
| CodeSystem - Test Category | | Removed | |
| CodeSystem - Time Point Description | | Removed | |
| Batch Designation Codes | Added | |
| Closure Type Codes | Added | |
| Container Orientation Codes | Added | |
| Device Property Codes | Added | |
| Diagram Type Codes | Added | |
| Drug Substance or Product Color Codes | Added | |
| Impurity Origin Codes | Added | |
| Impurity Type Codes | Added | |
| Ingredient Function Codes | Added | |
| Manufacturing Participant Role Codes | Added | |
| Manufacturing Step Scale Codes | Added | |
| Manufacturing Step Codes | Added | |
| Observation Qualified Value Criticality Codes | Added | |
| Package Grade Codes | Added | |
| Package Property Codes | Added | |
| Pharmaceutical Manufacturing Equipment Class Codes | Added | |
| Pharmaceutical Organization Type Codes | Added | |
| Pharmaceutical Plan Type Codes | Added | |
| Pharmaceutical Report Type Codes | Added | |
| Pharmaceutical Test Category Codes | Added | |
| Process Parameter Codes | Added | |
| Product Site Utilization Type Codes | Added | |
| Structure Characterization Technique Codes | Added | |
| Time Point Description Codes | Added | |
| ValueSets |
| FHIR Document Type Codes | Diagram Types | Comparison | Union | Intersection | 3 Breaking Changes, 0 Changes, 7 Notes |
| Goal Category | Equipment Classes | Comparison | Union | Intersection | 2 Breaking Changes, 1 Change, 6 Notes |
| Goal Priority | Goal Priority | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 5 Notes |
| Product Name Type | Product Name Type | Comparison | Union | Intersection | 2 Breaking Changes, 1 Change, 6 Notes |
| Organization Type | Pharmaceutical Organization Type | Comparison | Union | Intersection | 2 Breaking Changes, 1 Change, 6 Notes |
| Product Characteristic | Substance Property | Comparison | Union | Intersection | 3 Breaking Changes, 1 Change, 7 Notes |
| LOINC Diagnostic Report Codes | Report Type | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 7 Notes |
| Substance Relationship Type | Impurity Types | Comparison | Union | Intersection | 2 Breaking Changes, 1 Change, 7 Notes |
| Closure Type Terminology | | Removed | |
| MedicinalProduct Characteristic Type | | Removed | |
| MedicinalProduct Characteristic Type | MedicinalProduct Characteristic Type | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 5 Notes |
| Medicine Dose Form EDQM | | Removed | |
| Medicine Dose Form EDQM | Medicine Dose Form EDQM | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 1 Note |
| Medicine Route of Administration EDQM | | Removed | |
| Medicine Route of Administration EDQM | Medicine Route of Administration EDQM | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 1 Note |
| ValueSet - Batch Designation | | Removed | |
| ValueSet - Batch Designation | Batch Designation | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Batch Designation | Added | |
| Characterization Steps | Added | |
| Closure Types | Added | |
| Colors | Added | |
| ValueSet - Container Orientation | | Removed | |
| ValueSet - Container Orientation | Container Orientations | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Container Orientations | Added | |
| ISO Country two letter codes | Added | |
| ValueSet - Device Property | | Removed | |
| ValueSet - Device Property | Device Properties | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Device Properties | Added | |
| ValueSet - Device Type | | Removed | |
| ValueSet - Device Type | Device Type | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Device Type | Added | |
| Diagram Types | Added | |
| Equipment Classes | Added | |
| Goal Priority | Added | |
| Grades | Added | |
| ValueSet - Impurity Origin | | Removed | |
| ValueSet - Impurity Origin | Impurity Origins | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Impurity Origins | Added | |
| Impurity Types | Added | |
| ValueSet - Ingredient Function | | Removed | |
| ValueSet - Ingredient Function | Ingredient Function | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Ingredient Function | Added | |
| ValueSet - Manufactured Item Property | | Removed | |
| ValueSet - Manufactured Item Property | Manufactured Item Property | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Manufactured Item Property | Added | |
| Manufacturing Participant Role | Added | |
| ValueSet - Manufacturing Step | Action Code | Comparison | Union | Intersection | 27 Breaking Changes, 1 Change, 7 Notes |
| ValueSet - Manufacturing Step | | Removed | |
| Manufacturing Step | Added | |
| ValueSet - Manufacturing Step Scale | | Removed | |
| ValueSet - Manufacturing Step Scale | Manufacturing Step Scale | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Manufacturing Step Scale | Added | |
| MedicinalProduct Characteristic Type | Added | |
| Medicine Dose Form EDQM | Added | |
| Medicine Route of Administration EDQM | Added | |
| ValueSet - Package Property | | Removed | |
| ValueSet - Package Property | Package Property | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Package Property | Added | |
| Pharmaceutical Organization Type | Added | |
| ValueSet - Plan Type | | Removed | |
| ValueSet - Plan Type | Plan Type | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Plan Type | Added | |
| ValueSet - Process Validation Procedure | Process Validation Procedure | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 3 Notes |
| Process Parameter | Added | |
| Product Name Type | Added | |
| ValueSet - Product Site Utilization | | Removed | |
| ValueSet - Product Site Utilization | Product Site Utilization | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Product Site Utilization | Added | |
| ValueSet - Qualified Value Criticality | | Removed | |
| ValueSet - Qualified Value Criticality | Qualified Value Criticality | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Qualified Value Criticality | Added | |
| Report Type | Added | |
| Specification Type | Added | |
| Substance Property | Added | |
| Substance Property Value | Added | |
| ValueSet - Test Method | | Removed | |
| ValueSet - Test Method | Test Method | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Test Method | Added | |
| Test Category | Added | |
| ValueSet - Time Point Description | | Removed | |
| ValueSet - Time Point Description | Time Point Description | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Time Point Description | Added | |
| Action Participant Role | Manufacturing Participant Role | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 10 Notes |
| Action Participant Role | Test Category | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 10 Notes |
| 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 |
| ActivityDefinition - Test Drug PQ | ActivityDefinition - Test Drug PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Bundle – Analytical Procedure PQ | Bundle – Analytical Procedure PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle – Batch Analysis PQ | Bundle – Batch Analysis PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle – Batch Formula PQ | Bundle – Batch Formula PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle – Container Closure System PQ | Bundle – Container Closure System PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle – drug Product Batch Information PQ | Bundle – drug Product Batch Information PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle - Drug Product Compatibility PQ | Bundle - Drug Product Compatibility PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle – Drug Product Composition PQ | Bundle – Drug Product Composition PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle – Drug Product Excipients PQ | Bundle – Drug Product Excipients PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle – Drug Product Microbiological Attributes PQ | Bundle – Drug Product Microbiological Attributes PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle - Drug Product PQ | Bundle - Drug Product PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle – Drug Product Specification PQ | Bundle – Drug Product Specification PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle – Drug Reference Standards PQ | Bundle – Drug Reference Standards PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle – Drug Stability PQ | Bundle – Drug Stability PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle – Drug Substance Batch Information PQ | Bundle – Drug Substance Batch Information PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle – Drug Substance Characterization PQ | Bundle – Drug Substance Characterization PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle – Drug Substance General Properties PQ | Bundle – Drug Substance General Properties PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 2 Notes |
| Bundle – Drug Substance Specification PQ | Bundle – Drug Substance Specification PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle - Organizations PQ | Bundle - Organizations PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 2 Notes |
| Bundle - Product Impurities PQ | Bundle - Product Impurities PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle - Product Manufacturing PQ | Bundle - Product Manufacturing PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Bundle - Product Process Validation PQ | Bundle - Product Process Validation PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 3 Notes |
| Composition - Drug PQ | Composition - Drug PQ | Comparison | Union | Intersection | 2 Breaking Changes, 0 Changes, 2 Notes |
| DeviceDefinition - Drug PQ | DeviceDefinition - Drug PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| DiagnosticReport - Analysis Drug PQ | DiagnosticReport - Analysis Drug PQ | Comparison | Union | Intersection | 1 Breaking Change, 1 Change, 4 Notes |
| DocumentReference - Drug PQ | DocumentReference - Drug PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Extension - Actual Yield PQ | Extension - Actual Yield PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Actual Yield Unfiltered PQ | Extension - Actual Yield Unfiltered PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Batch Derived From PQ | Extension - Batch Derived From PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Batch Designation PQ | Extension - Batch Designation PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Batch Number of Full Shelves PQ | Extension - Batch Number of Full Shelves PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Batch Number of Items PQ | Added | |
| Extension - Batch Number of Partial Shelves PQ | Extension - Batch Number of Partial Shelves PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Batch Number of Vials PQ | Extension - Batch Number of Vials PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Batch Release Date PQ | Extension - Batch Release Date PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Batch Retest Date PQ | Extension - Batch Retest Date PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Batch Storage Duration PQ | Extension - Batch Storage Duration PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Batch Substance Batch PQ | Extension - Batch Substance Batch PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Container Orientation PQ | Extension - Container Orientation PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Extension - Formulation Number PQ | Extension - Formulation Number PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - History of Process PQ | Extension - History of Process PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Extension - Impurity Origin PQ | Extension - Impurity Origin PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Manufacturing Participant PQ | Extension - Manufacturing Participant PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Manufacturing Process PQ | Extension - Manufacturing Process PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Medication Definition PQ | Extension - Medication Definition PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Novel Excipient PQ | Extension - Novel Excipient PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Package Definition PQ | Extension - Package Definition PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Packaging Date PQ | Extension - Packaging Date PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Packaging Site PQ | Extension - Packaging Site PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Plan Document Reference PQ | Extension - Plan Document Reference PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Extension - Process Parameters PQ | Extension - Process Parameters PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Extension - Process Step Scale PQ | Extension - Process Step Scale PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Qualified Value Criticality PQ | Extension - Qualified Value Criticality PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Qualified Value Display PQ | Extension - Qualified Value Display PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Qualified Value Target PQ | Extension - Qualified Value Target PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Qualified Value Text PQ | Extension - Qualified Value Text PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Site Utilization PQ | Extension - Site Utilization PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Statistical Model PQ | Extension - Statistical Model PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Substance Property Parameter PQ | Extension - Substance Property Parameter PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Substance Property Range PQ | Extension - Substance Property Range PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Suitability for Use PQ | Extension - Suitability for Use PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension Target Fill Weight PQ | Extension Target Fill Weight PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| Extension - Test Comment PQ | Extension - Test Comment PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Extension - Time Point Description PQ | Extension - Time Point Description PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Ingredient - Drug Pq | Ingredient - Drug Pq | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 6 Notes |
| ManufacturedItemDefinition - Drug PQ | ManufacturedItemDefinition - Drug PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 5 Notes |
| Medication - Batch Information Drug PQ | Medication - Batch Information Drug PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 5 Notes |
| MedicinalProductDefinition - Drug Product PQ | MedicinalProductDefinition - Drug Product PQ | Comparison | Union | Intersection | 1 Breaking Change, 1 Change, 4 Notes |
| Observation - Test Result Drug PQ | Observation - Test Result Drug PQ | Comparison | Union | Intersection | 1 Breaking Change, 1 Change, 1 Note |
| ObservationDefinition - Test Method PQ | ObservationDefinition - Test Method PQ | Comparison | Union | Intersection | 1 Breaking Change, 1 Change, 13 Notes |
| Organization - Drug PQ | Organization - Drug PQ | Comparison | Union | Intersection | 1 Breaking Change, 1 Change, 20 Notes |
| PackagedProductDefinition - Drug PQ | PackagedProductDefinition - Drug PQ | Comparison | Union | Intersection | 1 Breaking Change, 2 Changes, 1 Note |
| PlanDefinition - Drug PQ | PlanDefinition - Drug PQ | Comparison | Union | Intersection | 1 Breaking Change, 6 Changes, 8 Notes |
| Procedure - Drug PQ | Procedure - Drug PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 7 Notes |
| Specimen - Drug PQ | Specimen - Drug PQ | Comparison | Union | Intersection | 1 Breaking Change, 1 Change, 3 Notes |
| SpecimenDefinition - Drug PQ | SpecimenDefinition - Drug PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 1 Note |
| Substance - Drug PQ | Substance - Drug PQ | Comparison | Union | Intersection | 1 Breaking Change, 0 Changes, 2 Notes |
| SubstanceDefinition - Component Substance Drug PQ | SubstanceDefinition - Component Substance Drug PQ | Comparison | Union | Intersection | 1 Breaking Change, 5 Changes, 7 Notes |