 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 |