药品及生物制品的分析方法和方法验证指导原则 目录 1.介绍...................... .......................................................................................... 1 2.背景..................... ........................................................................... ….............. 2 3.分析方法开发. ..................... ......................................................................... 3 4.分析程序内容.............................................. ......... ..................................... .. 3 A.原则/范围..................................................................................................... 4 B.仪器/设备............................................. ....................................................... 4 C.操作参数.............................................. ........................................................ 4 D.试剂/标准............................................. ....................................................... 4 E.样品制备.............................................. ........................................................ 4 F.标准对照品溶液的制备............................................ ................................... 5 G.步骤......... ....................................... ...............................................................5 H.系统适应性….. ............................................................................................. 5 I.计算................................................................................................................ 5 J.数据报告……………………………………………………………………………………….............. 5 5.参考标准和教材............................................ ................................................ 6 6 分析方法验证用于新药，仿制药， 生物制品和DMF .............................. 6 A.非药典分析方法............................................. .........................................
