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 Description and Composition of the Dru g Produ ct (name, dosage form) 3.2.P.2 产品开发 Pharmaceu tical Dev elopment 3.2.P.2.1 处方组成 Components of the Dru g Produ ct 3.2.P.2.1.1 原料药 Dru g Su bstance 3.2.P.2.1.2 辅料 Ex cipients 3.2.P.2.2 制剂 Dru g Produ ct 3.2.P.2.2.1 处方开发过程 Formu lation Dev elopment 3.2.P.2.2.2 制剂相关特性 Overages 3.2.P.2.2.3 Phy sicochemical and Biological Properties 3.2.P.2.3 生产工艺开发 Manu factu ring Process Dev elopment 3.2.P.2.4 包装材料容器 Container Closu re Sy stem 3.2.P.2.5 相容性 Microbiological attributes 3.2.P.2.6 Compatibility 3.2.P.3 生产 Manu factu re 3.2.P.3.1 生产商 Manu factu rer(s) 3.2.P.3.2 批处方 Batch Formu la 3.2.P.3.3 生产工艺和工艺控制 Description of Manu factu ring 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 Ev alu ation 3.2.P.4 辅料控制 Control of Ex cipients 3.2.P.4.1 Specifications 3.2.P.4.2 Analy tical procedu res 3.2.P.4.3 Validation of analy tical procedu res 3.2.P.4.4 Ju stification of specifications 3.2.P.4.5 Ex cipients of hu man or animal origin 3.2.P.4.6 Nov el ex cipients(ref to A 3) 3.2.P.5 制剂控制 Control of Dru g Produ ct 3.2.P.5.1 质量标准 Specifications 3.2.P.5.2 分析方法 Analy tical procedu res 3.2.P.5.3 分析方法验证 Validation of analy tical procedu res 3.2.P.5.4 批检验报告 Ju stification of specifications 3.2.P.5.5 杂质分析 Characterisation of Impu rities 3.2.P.5.6 质量标准依据 Ju stification of Specification(s) 3.2.P.6 对照品 Reference Standards or Materials 3.2.P.7 Container closu re sy stem 3.2.P.8 稳定性 Stability 3.2.P.8.1 稳定性...
