CTD格式申报料提交要求(药学部分：制剂——骨架篇)1.doc

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 Compatibility 3.2.P.3 生产 Manufacture 3.2.P.3.1 生产商 Manufacturer(s) 3.2.P.3.2 批处方 Batch Formula 3.2.P.3.3 生产工艺和工艺控制 Description of Manufacturing Process and Process Controls 3.2.P.3.4 关键步骤和中间体的控制 Controls of Critical Steps and Intermediates 3.2.P.3.5 工艺验证和评价 Process Validation and/or Evaluation 3.2.P.4 辅料控制 Control of Excipients 3.2.P.4.1 Specifications 3.2.P.4.2 Analytical procedures 3.2.P.4.3 Validation of analytical procedures 3.2.P.4.4 Justification of specifications 3.2.P.4.5 Excipients of human or animal origin 3.2.P.4.6 Novel excipients(ref to A 3) 3.2.P.5 制剂控制 Control of Drug Product 3.2.P.5.1 质量标准 Specifications 3.2.P.5.2 分析方法 Analytical procedures 3.2.P.5.3 分析方法验证 Validation of analytical procedures 3.2.P.5.4 批检验报告 Justification of specifications 3.2.P.5.5 杂质分析 Characterisation of Impurities 3.2.P.5.6 质量标准依据 Justification of Specification(s) 3.2.P.6 对照品 Reference Standards or Materials 3.2.P.7 Container closure system 3.2.P.8 稳定性 Stability 3.2.P.8.1 稳定性总结 Stability Summary and Conclusion 3.2.P.8.2 上市后稳定性研究方案和承诺 Post-approval Stability Protocol and Stability 3.2.P.8.3 稳定性数据 Stability Data 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A description of the drug product and its composition should be provided. The information provided should in