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已上市化学药品生产工艺变更研究

技术指导原则

目 录

一、概述 .................................................................................................................................. 二、已上市化学药品生产工艺变更研究工作的基本原则 .................................................. （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 ...................................... （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 ...... （三）研究用样品的选择原则 .............................................................................................. （四）关联变更的研究原则 .................................................................................................. 三、变更原料药生产工艺 ...................................................................................................... （一）总体考虑 ...................................................................................................................... （二）变更分类 ...................................................................................................................... 四、变更药品制剂生产工艺 .................................................................................................. （一）总体考虑 ...................................................................................................................... （二）处方变更分类 .............................................................................................................. （三）工艺变更分类 .............................................................................................................. 原料药： .................................................................................................................................. （一）品种概述 ...................................................................................................................... （二）立题合理性 .................................................................................................................. （三）变更内容及变更理由 .................................................................................................. （四）变更研究 ...................................................................................................................... 口服固体制剂： ...................................................................................................................... （一）品种概述 ......................................................................................................................

（二）立题合理性 .................................................................................................................. （三）变更内容及变更理由 .................................................................................................. （四）变更研究 ...................................................................................................................... 注射剂： .................................................................................................................................. （一）品种概述 ...................................................................................................................... （二）立题合理性 .................................................................................................................. （三）变更内容及变更理由 .................................................................................................. （四）变更研究 ......................................................................................................................