0 Table of Contents |
1 Home |
2 Product Description and Composition of the Drug Product |
3 Substance General Information |
4 Substance Control of Materials |
5 Quality Specification |
6 General Instructions |
7 Downloads |
8 Change Notes |
9 Artifacts Summary |
9.1 Manufacturing and/or Test Site Organization |
9.2 Sponsor Organization |
9.3 Supplier Organization |
9.4 CMC eCTD 32P10 Document |
9.5 CMC eCTD 32S10 Document |
9.6 CMC eCTD 32S23 Document |
9.7 CMC eCTD SP4151 Document |
9.8 Component Substance |
9.9 Document Reference Attachment |
9.10 Drug Product Component |
9.11 Drug Product Container Closure |
9.12 Drug Product Description |
9.13 eCTD Product Description and Composition |
9.14 eCTD Specification Composition |
9.15 eCTD Substance Control of Materials Composition |
9.16 eCTD Substance General Information |
9.17 Excipient Drug Substance |
9.18 Manufactured Drug Product |
9.19 Polymorphic Form |
9.20 Quality Specification |
9.21 Routine Drug Product |
9.22 Routine Drug Substance |
9.23 Substance General Information |
9.24 PqAddress |
9.25 Additional Information |
9.26 Container Closure |
9.27 Content Percent |
9.28 Hierarchical Level |
9.29 Interpretation Code |
9.30 Optional Denominator |
9.31 Profile IG Version |
9.32 Specification Type |
9.33 Strength Extension |
9.34 Test Order | Stage Sequence Order |
9.35 Chemical Structure Data File Type Terminology |
9.36 Closure Type Terminology |
9.37 Coating Purpose Terminology |
9.38 Code System PQCMC Product Characteristic |
9.39 Conformance to Criteria Terminology |
9.40 Container Type Terminology |
9.41 Drug Product Component Function Category Terminology |
9.42 Drug Route Of Administration Terminology |
9.43 eCTD sections Terminology |
9.44 EVMPD Substance Classification |
9.45 Excipient Function Terminology |
9.46 GENC Country Codes |
9.47 Interpretation Code Terminology |
9.48 Manufactured Dose Form Terminology |
9.49 Name Part Terminology |
9.50 Pharmaceutical Dosage Form Terminology |
9.51 PQ/CMC Capsule Shell Classification Terminology |
9.52 Product Name Types Terminology |
9.53 Product Part Ingredient Physical Location Terminology |
9.54 Product Part Type Terminology |
9.55 Quality Standard Terminology |
9.56 Relationship Types Terminology |
9.57 Release Mechanism Terminology |
9.58 Release Profile Terminology |
9.59 Source Type Terminology |
9.60 Specification Status Terminology |
9.61 Specification Type Terminology |
9.62 Strength Operator Terminology |
9.63 Strength Type Terminology |
9.64 Substance Name Type |
9.65 Test Category Terminology |
9.66 Test Method Origin Terminology |
9.67 Test Usage Terminology |
9.68 Testing Site and Organization Identifier Type Terminology |
9.69 Units Of Measure Terminology |
9.70 Code System PQCMC Comp Section Types |
9.71 Dummy EMA Codesystem |
9.72 Dummy NCIT Codesystem |
9.73 GENC Country Codes |
9.74 Hierarchical Test Category Codes |
9.75 Product Name Types Code Types |
9.76 Relationship Types Codes |
9.77 ISO to GENC Country Code Mapping |
9.78 A DrugProductContainerClosure |
9.79 A DrugProductDescription for a multilayer product |
9.80 A FinishedProduct profile based on ManufacturedItemDefinition |
9.81 A quality specification is for a drug product |
9.82 A quality specification is for a drug substance |
9.83 Base64 Document Reference - L-thyroxine-3D-structure-CT1000583834.sdf |
9.84 Base64 Document Reference - Levothyroid.png |
9.85 Base64 Document Reference - Monosodium_D-thyroxine_hydrate.png |
9.86 Bundle for 3.2.S.1 |
9.87 Carrageenan specification Example |
9.88 Citric acid specification Example |
9.89 CMCeCTDDocument32P10 bundle |
9.90 Composition ingredient substance indentifying information - acetaminophen |
9.91 Composition ingredient substance indentifying information - aspirin |
9.92 Composition ingredient substance indentifying information - Maize starch |
9.93 Drug Manufacturing Site - Vandechemie |
9.94 drug product for specification |
9.95 Drug Substance Nomenclature and Structure |
9.96 DrugProductComponent example for an excipient - Maize starch |
9.97 East-West Manufacturing |
9.98 eCTD Composition for 3.2.S.1 |
9.99 eCTD Document for 32S23 |
9.100 eCTD Drug Substance Specification Composition SP4151 |
9.101 eCTD Product Specification Composition SP4151 |
9.102 EctdComposition32P10 for 2 layer tablet |
9.103 Example Composition for CTD 3.2.S.2.3 |
9.104 Example of a Supplier Organization |
9.105 Example of MfgTestSiteOrganization profile on Organization |
9.106 Example RoutineSubstanceDefinition |
9.107 Example RoutineSubstanceDefinition for Asprin |
9.108 Example SubstanceDefinition for anhydrous citric acid |
9.109 Example SubstanceDefinition for Carrageenan |
9.110 Example SubstanceDefinition for water |
9.111 FHIR Document example of 3.2.P.4.1. |
9.112 FHIR Document example of 3.2.P.5.1. |
9.113 IngredComponentSubstance example showing the use of the sourceMaterial backbone element |
9.114 Manufacturing Site (J. Jones Research) |
9.115 Polymorphic Form Example |
9.116 Sponsor of API |
9.117 SponsorOrganization - Wunderwerke |
9.118 SponsorOrganization J. Jones Research |
9.119 Strength info for the Active Ingredient |
9.120 Strength information - Grape skin extract |
9.121 Strength information for the Active Ingredient - acetaminophen |
9.122 Vidinaid |
9.123 Water Specification Example |