化学药品 3 类注册申请 药学自评估报告（原料药） （征求意见稿） 目 录 一、品种概述 ................................ ................................ ................................ ...................... 1 （一）品种信息 ................................ ................................ ................................ ........... 1 （二）证明性文件信息 ................................ ................................ ............................... 1 （三）申报经过 /情况 ................................ ................................ ................................ .. 2 （四）注册检验情况 ................................ ................................ ................................ ... 3 二、药学研究自评估 ................................ ................................ ................................ ........... 3 2.3.S.1 基本信息 ................................ ................................ ................................ .......... 3 2.3.S.1.1 药品名称 ................................ ................................ ............................... 3 2.3.S.1.2 结构 ................................ ................................ ................................ ....... 3 2.3.S.1.3 基本性质 ................................ ................................ ............................... 3 2.3.S.2 生产 ................................ ................................ ................................ ................. 4 2.3.S.2.1 生产商 ................................ ................................ ................................ ... 4 2.3.S.2.2 生产工艺和工艺控制 ................................ ................................ ............ 4 2.3.S.2.3 物料控制 ................................ ................................ ............................... 7 2.3.S.2.4 关键步骤和中间体的控制 ................................ ................................ ... 10 2.3.S.2.5 工艺验证 ................................ ................................ ............................. 12 2.3.S.2.6 生产工艺的开发 ................................ ................................ .................. 13 2.3.S.3. 特性鉴定 ................................ ................................ ................................ ....... 14 2.3.S.3.1 结构和理 化性质 ................................ ................................ .................. 14 2.3.S.3.2 杂质 ................................ ................................ ................................ ..... 16 2.3.S.4 原料药的质量控制 ................................ ................................ ........................ 17 2.3.S.4.1 质量 标准 ................................ ................................ ............................. 17 2.3.S.4.2 分析方法 ................................ ................................ ............................. 19 2.3.S.4.3 分析方法的验证 ................................ ................................ .................. 21 2.3.S.4.4 批分析 ................................ ................................ ................................ . 23 2.3.S.4.5 质量标准制定依据 ................................ ................................ .............. 24 2.3.S.5 对照品 ................................ ................................ ................................ ............ 24 2.3.S.6 包装系统 ................................ ................................ ................................ ........ 25 2.3.S.7 稳定性 ................................ ................................ ................................ ............ 25 2.3.S.7.1 稳定性总结和结论 ................................ ................................ ............... 25 2.3.S.7.2 批准后稳定性研究方案和承诺 ................................ ........................... 26 2.3.S.7.3 稳定性数据 ................................ ................................ ......................... 26