附件已上市化学药品生产工艺变更研究技术指导原则—1——目录一、概述....................................................................................................................................................4二、已上市化学药品生产工艺变更研究工作的基本原则.....................................................................4（一）持有人是生产工艺变更研究和研究结果自我评估的主体.........................................................4（二）全面、综合评估生产工艺变更对药品安全性、有效性和质量可控性的影响.........................4（三）研究用样品的选择原则................................................................................................................6（四）关联变更的研究原则....................................................................................................................6三、变更原料药生产工艺........................................................................................................................6（一）总体考虑........................................................................................................................................6（二）变更分类........................................................................................................................................8四、变更药品制剂生产工艺....................................................................................................................9（一）总体考虑........................................................................................................................................9（二）处方变更分类..............................................................................................................................10（三）工艺变更分类..............................................................................................................................15原料药：..................................................................................................................................................17（一）品种概述......................................................................................................................................17（二）立题合理性..................................................................................................................................17（三）变更内容及变更理由..................................................................................................................17（四）变更研究......................................................................................................................................18口服固体制剂：......................................................................................................................................22（一）品种概述......................................................................................................................................22（二）立题合理性..................................................................................................................................22（三）变更内容及变更理由..................................................................................................................22（四）变更研究......................................................................................................................................2...
