化学药物质量标准建立的规范化过程技术指导原则

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1、【H】GPH1-1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、···············································································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、·····················································································3（五）质量标准的修订·····························································································4三、药物的质量研究····································································································

4、····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························

5、·············································································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··

6、··································································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·································

7、······································································22（一）质量标准修订的必要性·············································································22（二）质量标准修订的一般原则····························