CTD格式申报料提交要求(药学部分：制剂——骨架篇)1.docVIP

CTD格式申报资料提交要求 （药学部分：制剂） 目录CTD (ICH) 3.2.P.1 剂型及产品组成 Description and Composition of the Drug Product (name, dosage form) 3.2.P.2 产品开发 Pharmaceutical Development 3.2.P.2.1 处方组成 Components of the Drug Product 3.2.P.2.1.1 原料药 Drug Substance 3.2.P.2.1.2 辅料 Excipients 3.2.P.2.2 制剂 Drug Product 3.2.P.2.2.1 处方开发过程 Formulation Development 3.2.P.2.2.2 制剂相关特性 Overages 3.2.P.2.2.3 Physicochemical and Biological Properties 3.2.P.2.3 生产工艺开发 Manufacturing Process Development 3.2.P.2.4 包装材料容器 Container Closure System 3.2.P.2.5 相容性 Microbiological attributes 3.2.P.2.6 C