CTD制剂部分学习之——骨架篇.doc

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1、CTD格式申报资料提交要求（药学部分：制剂——骨架篇）目录内容CCTD(China)CTD(ICH)3.2.P.1剂型及产品组成DescriptionandCompositionoftheDrugProduct(name,dosageform)3.2.P.2产品开发PharmaceuticalDevelopment3.2.P.2.1处方组成ComponentsoftheDrugProduct3.2.P.2.1.1原料药DrugSubstance3.2.P.2.1.2辅料Excipients3.2.P.2.2制剂DrugProduct3.2.P.2.

2、2.1处方开发过程FormulationDevelopment3.2.P.2.2.2制剂相关特性Overages3.2.P.2.2.3PhysicochemicalandBiologicalProperties3.2.P.2.3生产工艺开发ManufacturingProcessDevelopment3.2.P.2.4包装材料容器ContainerClosureSystem3.2.P.2.5相容性Microbiologicalattributes3.2.P.2.6Compatibility3.2.P.3生产Manufacture3.2.P.3.1生

3、产商Manufacturer(s)3.2.P.3.2批处方BatchFormula3.2.P.3.3生产工艺和工艺控制DescriptionofManufacturingProcessandProcessControls3.2.P.3.4关键步骤和中间体的控制ControlsofCriticalStepsandIntermediates3.2.P.3.5工艺验证和评价ProcessValidationand/orEvaluation3.2.P.4辅料控制ControlofExcipients3.2.P.4.1Specifications3.2.P.

4、4.2Analyticalprocedures3.2.P.4.3Validationofanalyticalprocedures3.2.P.4.4Justificationofspecifications3.2.P.4.5Excipientsofhumanoranimalorigin3.2.P.4.6Novelexcipients(reftoA3)3.2.P.5制剂控制ControlofDrugProduct3.2.P.5.1质量标准Specifications3.2.P.5.2分析方法Analyticalprocedures3.2.P.5.3分析

5、方法验证Validationofanalyticalprocedures3.2.P.5.4批检验报告Justificationofspecifications3.2.P.5.5杂质分析CharacterisationofImpurities3.2.P.5.6质量标准依据JustificationofSpecification(s)3.2.P.6对照品ReferenceStandardsorMaterials3.2.P.7Containerclosuresystem3.2.P.8稳定性Stability3.2.P.8.1稳定性总结StabilityS

6、ummaryandConclusion3.2.P.8.2上市后稳定性研究方案和承诺Post-approvalStabilityProtocolandStability3.2.P.8.3稳定性数据StabilityData个人定义CTD：ICH的要求，英文水平所限，仅罗列上，没有核对。CCTD：中国式CTD，主要来自CDE发布的讨论稿模板，和重庆培训的相关内容。申报资料正文及撰写要求3.2.P.1剂型及产品组成CTDAdescriptionofthedrugproductanditscompositionshouldbeprovided.Theinf

7、ormationprovidedshouldinclude,forexample:·DescriptionForadrugproductsuppliedwithreconstitutiondiluent(s),theinformationonthediluent(s)shouldbeprovidedinaseparatepart“P”,asappropriateofthedosageform;·Composition,i.e.,listofallcomponentsofthedosageform,andtheiramountonaper-unitb

8、asis(includingoverages,ifany)thefunctionofthecomponents,andar