ACTD目录.docxVIP

A- DRUG SUBSTANCES1. General InformationS.1.1 NomenclatureS.1.2 Structural formulaS.1.3 General PropertiesS2. ManufactureS2.1 Manufacturer (s) S2.2 Description of Mfg. Process and Process Controls S2.3 Control of MaterialsS2.4 Control of Critical Steps and IntermediatesS2.5 Process validation and /or EvaluationS2.6 Manufacturing Process DevelopmentS3. CharacterizationS3.1 Elucidation of structure characteristicsS3.2 ImpuritiesS4. Control of Drug SubstanceS4.1 SpecificationS4.2 Analytical ProcedureS4.3 Validation of Analytical ProceduresS4.4 Batch AnalysisS4.5 Justification of Specification S5. Reference Standards or MaterialsS6. Container Closure SystemS7. StabilityStability Summary ConclusionPost-approval Stability Protocol Stability CommimentStability Summary DataB- DRUG PRODUCTP1. Description and CompositionP2. Pharmaceutical DevelopmentP2.1 Information on Development StudiesP2.2Component of Drug Product P2.2.1 Active ingredient P2.2.2 ExcipientsP2.3Finished product P2.3.1 Formulation Development P2.3.2 Overages P2.3.3 Physicochemical and Biological PropertiesP2.4 Manufacturing Process DevelopmentP2.5 Container Closure SystemP2.6 Microbiological AttributesP2.7 Compatibility P3. ManufactureP3.1 Batch formulaP3.2 Manufacturing Process and Process ControlP3.3 Controls of Critical Steps and IntermediatesP3.4 Process Validation and/or EvaluationP4. Control of ExcipientsP4.1 SpecificationP4.2 Analytical ProceduresP4.3 Excipients of Human and Animal OriginP4.4 Novel ExcipientsP5. Control of Drug (Finished) ProductP5.1 SpecificationP5.2 Analytical ProcedureP5.3 Validation of Analytical ProcedureP5.4 Batch AnalysisP5.5 Characterization of ImpuritiesP5.6 Justification of SpecificationP6. Reference Standards or Materials P7. Container Closure SystemP8. StabilityStability Summary and ConclusionPost-approval stability and stability commitmentStability dataP9. Product InterchangeabilityTable of ContentsMODULE 1: ADMINISTRATIVE INFORMATION AND PRESCRIBING INFO