美国药品质量控制理念在我国药品抽验中的应用  

The Application of the Ideas of US Drug Quality Control into Our National Sampling Inspection of Medicine

作　　者：孙苓苓[1,2] 毕开顺[1] 

机构地区：[1]沈阳药科大学,沈阳110016 [2]辽宁省食品药品检验所

出　　处：《中国药事》2012年第7期671-673,677,共4页Chinese Pharmaceutical Affairs

摘　　要：目的为探索我国药品抽验发展方向提供参考。方法介绍美国的药品质量控制方法,分析美国保证该方法顺利实施的先进理念,以利于我国药品抽验工作借鉴。结果与结论通过转变思路,可以将美国的源头控制、过程控制、惩罚控制理念应用于我国药品抽验工作中,进而从抽验目标转变、抽验过程控制、抽验结果处理的角度提高我国药品抽验工作的效率。Objective To provide a reference for the exploration of the development of national drug sampling inspection. Methods Through introducing the methods of quality control in US and analyzing the advanced concepts ensuring its smooth operation, to provide a reference for national sampling inspection. Results and Conclusion By changing the thoughts, the source control, process control and penalty control in US could be applied to the national sampling inspection, so that they could improve the work efficiency by target changing, process control, and result disposing.

关 键 词：美国药品质量控制 药品抽验 

分 类 号：R927.11[医药卫生—药学]