化学药物质量标准建立的规范化过程技术指导原则..doc

指导原则编号： 化学药物质量标准建立的规范化过程 技术指导原则 二○○五年三月 目 录 一、概述·································································································································1 二、质量标准建立的基本过程·······················································································1 （一）质量研究内容的确定····················································································2 （二）方法学研究··········································································································3 （三）质量标准项目及限度的确定······································································3 （四）质量标准的制订·····························································································3 （五）质量标准的修订·····························································································4 三、药物的质量研究········································································································5 （一）质量研究用样品和对照品··········································································5 （二）原料药质量研究的一般内容·····································································5 （三）制剂质量研究的一般内容········································································10 （四）方法学研究·····································································································13 四、质量标准的制订·······································································································19 （一）质量标准制订的一般原则·········································································19 （二）质量标准项目和限度的确定····································································19 （三）质量标准的格式和用语··············································································21 （四）质量标准的起草说明··················································································21 五、质量标准的修订·······································································································22 （一）质量标准修订的必要性···········································