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国家药品标准物质分装情况简介
引用本文:谢丽华,赵宗阁,曹丽梅.国家药品标准物质分装情况简介[J].中国药事,2012,26(9):967-969.
作者姓名:谢丽华  赵宗阁  曹丽梅
作者单位:中国食品药品检定研究院,北京,100050
摘    要:目的 讨论影响药品标准物质分装质量的因素.方法 建立完善的质量管理体系.结果与结论 应不断积累经验,归纳出不同标准物质适宜的分装方法,提高分装工作效率,确保分装质量.

关 键 词:药品标准物质  分装  质量管理

Introduction of Current Situation of National Pharmaceutical Reference Standard Sub-packaging
Xie Lihua , Zhao Zongge , Cao Limei.Introduction of Current Situation of National Pharmaceutical Reference Standard Sub-packaging[J].Chinese Pharmaceutical Affairs,2012,26(9):967-969.
Authors:Xie Lihua  Zhao Zongge  Cao Limei
Institution:(National Institutes for Food and Drug Control,Beijing 100050)
Abstract:Objective To investigate influence factors for sub-packaging of national pharmaceutical reference standards which have been widely used for quality control of pharmaceutical products and for the verification of instrumental parameters Methods Regulations for the process of sub-packaging were established.The key steps of sub-packaging of reference standards and the issues regarding of quality control of these substances were discussed.Results and Conclusion Suitable sub-packaging methods should be developed for each kind of reference standards which would make the substantial work of drug control more effective and efficient,and relative experience should be summarized accordingly.
Keywords:pharmaceutical reference standards  sub-packaging of drugs  quality management
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