![.](tbl_spacer.png) 0 Table of Contents |
![.](tbl_spacer.png) ![.](tbl_vjoin.png) 1 Home Page |
![.](tbl_spacer.png) ![.](tbl_vjoin.png) 2 Business Use Cases |
![.](tbl_spacer.png) ![.](tbl_vjoin-open.png) 3 Domains Overview |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vjoin-open.png) 3.1 Analytical Procedures |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin.png) 3.1.1 Analytical Procedures: synthetic data rendering - drug product |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin_end.png) 3.1.2 Analytical Procedures: synthetic data rendering - drug substance |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vjoin-open.png) 3.2 Batch Analysis |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin.png) 3.2.1 Batch Analysis: synthetic data rendering - drug product |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin_end.png) 3.2.2 Batch Analysis: synthetic data rendering - drug substance |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vjoin-open.png) 3.3 Batch Formula |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin_end.png) 3.3.1 Batch Formula: synthetic data rendering - drug product |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vjoin-open.png) 3.4 Batch/Lot Information |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin.png) 3.4.1 Batch/Lot Information: synthetic data rendering - drug product |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin_end.png) 3.4.2 Batch/Lot Information: synthetic data rendering - drug substance |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vjoin-open.png) 3.5 Compatibility |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin_end.png) 3.5.1 Compatibility: synthetic data rendering - drug product |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vjoin-open.png) 3.6 Composition |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin.png) 3.6.1 Composition: synthetic data rendering - drug product |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin_end.png) 3.6.2 Composition: synthetic data rendering - drug substance |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vjoin-open.png) 3.7 Container Closure System |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin.png) 3.7.1 Container Closure System: synthetic data rendering - drug product |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin_end.png) 3.7.2 Container Closure System: synthetic data rendering - drug substance |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vjoin-open.png) 3.8 Drug Specification |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin.png) 3.8.1 Drug Specification: synthetic data rendering - drug product |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin_end.png) 3.8.2 Drug Specification: synthetic data rendering - drug substance |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vjoin-open.png) 3.9 Identification |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin.png) 3.9.1 Identification: synthetic data rendering - drug product |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin.png) 3.9.2 Identification: synthetic data rendering - drug product microbiological attributes |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin.png) 3.9.3 Identification: synthetic data rendering - drug product excipients |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin.png) 3.9.4 Identification: synthetic data rendering - drug substance general properties |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin_end.png) 3.9.5 Identification: synthetic data rendering - drug substance characterisation, elucidation of structure |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vjoin-open.png) 3.10 Impurities |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin.png) 3.10.1 Impurities: synthetic data rendering - drug product |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin_end.png) 3.10.2 Impurities: synthetic data rendering - drug substance |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vjoin-open.png) 3.11 Manufacturing Process |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin.png) 3.11.1 Manufacturing Process: synthetic data rendering - drug product |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin_end.png) 3.11.2 Manufacturing Process: synthetic data rendering - drug substance |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vjoin-open.png) 3.12 Organizations |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin_end.png) 3.12.1 Organizations: synthetic data rendering |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vjoin-open.png) 3.13 Process Validation |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin.png) 3.13.1 Process Validation: synthetic data rendering - drug product |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin.png) 3.13.2 Process Validation: synthetic data rendering - drug product, biologic |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vline.png) ![.](tbl_vjoin_end.png) 3.13.3 Process Validation: synthetic data rendering - drug substance |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_vjoin_end-open.png) 3.14 Stability Study |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 3.14.1 Stability Study: synthetic data rendering - drug product |
![.](tbl_spacer.png) ![.](tbl_vline.png) ![.](tbl_blank.png) ![.](tbl_vjoin_end.png) 3.14.2 Stability Study: synthetic data rendering - drug substance |
![.](tbl_spacer.png) ![.](tbl_vjoin.png) 4 General Principles & Design |
![.](tbl_spacer.png) ![.](tbl_vjoin.png) 5 Downloads |
![.](tbl_spacer.png) ![.](tbl_vjoin_end-open.png) 6 Artifacts Summary |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.1 Bundle - Analytical Procedure |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.2 Bundle - Batch Analysis |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.3 Bundle - Batch Formula |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.4 Bundle - Product Batch Information |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.5 Bundle - Substance Batch Information |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.6 Bundle - Product Compatibility |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.7 Bundle - Product Composition |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.8 Bundle - Reference Standards |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.9 Bundle - Container Closure System |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.10 Bundle - Product Specification |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.11 Bundle - Substance Specification |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.12 Bundle - Drug Product |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.13 Bundle - Product Microbiological Attributes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.14 Bundle - Product Excipients |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.15 Bundle - Substance General Properties |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.16 Bundle - Substance Characterization |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.17 Bundle - Impurities |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.18 Bundle - Manufacturing |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.19 Bundle - Organizations |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.20 Bundle - Process Validation |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.21 Bundle - Stability |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.22 Example: Bundle – Analytical Procedure, product |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.23 Example: Bundle – Analytical Procedure, substance |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.24 Example: Bundle – Batch Analysis, product |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.25 Example: Bundle – Batch Analysis, substance |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.26 Example: Bundle - Batch Formula |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.27 Example: Bundle – Product Batch Information |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.28 Example: Bundle – Substance Batch Information |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.29 Example: Bundle – Product Compatibility |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.30 Example: Bundle – Product Composition |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.31 Example: Bundle – Reference Standards, substance |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.32 Example: Bundle - Container Closure System, product |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.33 Example: Bundle - Container Closure System, substance |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.34 Example: Bundle – Product Specification |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.35 Example: Bundle – Substance Specification |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.36 Example: Bundle – Drug Product |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.37 Example: Bundle – Product Microbiological Attributes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.38 Example: Bundle – Product Excipients |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.39 Example: Bundle – Substance General Properties |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.40 Example: Bundle – Substance Characterization |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.41 Example: Bundle - Impurities, product |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.42 Example: Bundle - Impurities, substance |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.43 Example: Bundle - Manufacturing, product |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.44 Example: Bundle - Manufacturing, substance |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.45 Example: Bundle - Organizations |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.46 Example: Bundle - Process Validation, product |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.47 Example: Bundle - Process Validation, biologic product |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.48 Example: Bundle - Process Validation, substance |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.49 Example: Bundle – Stability, product |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.50 Example: Bundle – Stability, substance |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.51 ActivityDefinition - Test |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.52 Composition - Drug |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.53 DeviceDefinition - Drug |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.54 DiagnosticReport - Drug Analysis |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.55 DocumentReference - Drug |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.56 Ingredient - Drug |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.57 ManufacturedItemDefinition - Drug |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.58 Medication - Batch Information |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.59 MedicinalProductDefinition - Drug Product |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.60 Observation - Test Result |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.61 ObservationDefinition - Test Method |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.62 Organization - Drug |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.63 PackagedProductDefinition - Drug |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.64 PlanDefinition - Drug |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.65 Procedure - Drug |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.66 Specimen - Drug |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.67 SpecimenDefinition - Drug |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.68 Substance - Drug |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.69 SubstanceDefinition - Component Drug |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.70 ActivityDefinition - Test - example 1 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.71 ActivityDefinition - Test - example 2 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.72 Composition - Drug - example, formulation |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.73 Composition - Drug - example, risk |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.74 DeviceDefinition - Drug - example |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.75 DiagnosticReport - Drug Analysis - example, stability |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.76 DocumentReference - Drug - example |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.77 Ingredient - Drug - example |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.78 ManufacturedItemDefinition - Drug - example 1 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.79 ManufacturedItemDefinition - Drug - example 2 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.80 Medication - Batch Information - example |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.81 MedicinalProductDefinition - Drug Product - example |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.82 Observation - Test Result - example 1 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.83 Observation - Test Result - example 2 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.84 ObservationDefinition - Test Method - example 1, longTerm25X |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.85 ObservationDefinition - Test Method - example 2, Water |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.86 Organization - Drug - example 1, manufacturer |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.87 Organization - Drug - example 2, manufacturer |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.88 Organization - Drug - example 3, packaging |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.89 Organization - Drug - example 4, packaging |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.90 Organization - Drug - example 5, testing lab |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.91 PackagedProductDefinition - Drug - example |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.92 PlanDefinition - Drug - example, validation protocol |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.93 PlanDefinition - Drug - example, manufacturing plan |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.94 PlanDefinition - Drug - example, drug specification |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.95 PlanDefinition - Drug - example, manufacturing process |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.96 PlanDefinition - Drug - example, stability study protocol |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.97 Procedure - Drug - example 1 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.98 Procedure - Drug - example 2 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.99 Specimen - Drug - example |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.100 SpecimenDefinition - Drug - example 1 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.101 SpecimenDefinition - Drug - example 2 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.102 SpecimenDefinition - Drug - example 3 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.103 Substance - Drug - example |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.104 SubstanceDefinition - Component Drug - example 1 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.105 SubstanceDefinition - Component Drug - example 2 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.106 SubstanceDefinition - Component Drug - example 3 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.107 accelerated40X |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.108 accelerated40Y |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.109 accelerated40Z |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.110 longTerm25Y |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.111 longTerm25Z |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.112 longTerm30X |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.113 longTerm30Y |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.114 Assay |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.115 Degradation |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.116 Description |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.117 Identification |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.118 Impurities |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.119 Microbiological |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.120 Uniformity |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.121 observation-test-result-longterm25c-initial-1 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.122 observation-test-result-lt25c-i1-degradation-imp2 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.123 observation-test-result-lt25c-i1-degradation-imp3 |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.124 observation-test-result-lt25c-i1-degradation-imp-total |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.125 observation-test-result-lt25c-i1-degradation-imp-unspecified |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.126 observation-test-result-lt25c-i1-microbiological |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.127 observation-test-result-lt25c-i1-uniformity |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.128 observation-test-result-lt25c-i1-water |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.129 Extension - Actual Yield |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.130 Extension - Actual Yield Unfiltered |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.131 Extension - Batch Derived From |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.132 Extension - Batch Designation |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.133 Extension - Batch Number of Items |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.134 Extension - Batch Number of Full Shelves |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.135 Extension - Batch Number of Partial Shelves |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.136 Extension - Batch Number of Vials |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.137 Extension - Batch Release Date |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.138 Extension - Batch Retest Date |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.139 Extension - Batch Storage Duration |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.140 Extension - Batch Substance Batch |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.141 Extension - Container Orientation |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.142 Extension - Formulation Number |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.143 Extension - History of Process |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.144 Extension - Impurity Origin |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.145 Extension - Manufacturing Participant |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.146 Extension - Manufacturing Process |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.147 Extension - Medication Definition |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.148 Extension - Novel Excipient |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.149 Extension - Package Definition |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.150 Extension - Packaging Date |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.151 Extension - Packaging Site |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.152 Extension - Plan Document Reference |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.153 Extension - Process Parameters |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.154 Extension - Process Step Scale |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.155 Extension - Qualified Value Criticality |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.156 Extension - Qualified Value Display |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.157 Extension - Qualified Value Target |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.158 Extension - Qualified Value Text |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.159 Extension - Site Utilization |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.160 Extension - Statistical Model |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.161 Extension - Substance Property Parameter |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.162 Extension - Substance Property Range |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.163 Extension - Suitability For Use |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.164 Extension - Target Fill Weight |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.165 Extension - Test Comment |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.166 Extension - Time Point Description |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.167 Batch Designation |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.168 Characterization Steps |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.169 Closure Types |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.170 Colors |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.171 Container Orientations |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.172 ISO Country two letter codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.173 Device Properties |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.174 Device Type |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.175 Diagram Types |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.176 Equipment Classes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.177 Goal Priority |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.178 Grades |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.179 Impurity Origins |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.180 Impurity Types |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.181 Ingredient Function |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.182 Manufactured Item Property |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.183 Manufacturing Participant Role |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.184 Manufacturing Step |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.185 Manufacturing Step Scale |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.186 MedicinalProduct Characteristic Type |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.187 Medicine Dose Form EDQM |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.188 Medicine Route of Administration EDQM |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.189 Package Property |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.190 Pharmaceutical Organization Type |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.191 Plan Type |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.192 Process Validation Procedure |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.193 Process Parameter |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.194 Product Name Type |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.195 Product Site Utilization |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.196 Qualified Value Criticality |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.197 Report Type |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.198 Specification Type |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.199 Substance Property |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.200 Substance Property Value |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.201 Test Method |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.202 Test Category |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.203 Time Point Description |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.204 Batch Designation Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.205 Closure Type Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.206 Container Orientation Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.207 Device Type - example |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.208 Goal Priority - example |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.209 Example Local Codes - Drug |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.210 Manufactured Item Property - example |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.211 Product Name Type - example |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.212 Specification Type - example |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.213 Substance Property - example |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.214 Substance Property Value - example |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.215 Device Property Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.216 Diagram Type Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.217 Drug Substance or Product Color Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.218 Impurity Origin Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.219 Impurity Type Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.220 Ingredient Function Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.221 Manufacturing Participant Role Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.222 Manufacturing Step Scale Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.223 Manufacturing Step Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.224 Observation Qualified Value Criticality Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.225 Package Grade Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.226 Package Property Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.227 Pharmaceutical Manufacturing Equipment Class Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.228 Pharmaceutical Organization Type Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.229 Pharmaceutical Plan Type Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.230 Pharmaceutical Report Type Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.231 Pharmaceutical Test Category Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.232 Process Parameter Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.233 Product Site Utilization Type Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin.png) 6.234 Structure Characterization Technique Codes |
![.](tbl_spacer.png) ![.](tbl_blank.png) ![.](tbl_vjoin_end.png) 6.235 Time Point Description Codes |