北京市药品生产企业抽验品种不合格现状及成因分析

The Status Quo and Cause of Beijing Drugs Selective Acceptance

目的探讨北京市药品生产企业生产的药品抽验品种不合格情况及其产生的主要原因,从而为药监部门对药品生产企业的管理及抽验工作提供新思路。方法通过对2004~2006年外埠及北京市药品监督管理局抽验的北京市药品生产企业生产的药品经检验不符合规定的情况进行调研,获取第一手资料并进行分析。结果与结论通过总结归纳发现案例中存在的共性问题,为监管者改进工作提出切实可行的对策及建议。

Objective To provide some practical and fresh ideas to better deal with drug ministration and testing work. Methods By research and analysis on first--hand cases database of defective drugs manufactured by Beijing producers sampled by Beijing Drug Administration or drug administrations in other provinces from 2004 to 2006, this paper is trying to dig out the main reasons causing these failure in selective acceptance. Results and Conclusions There are some similarities in cases of 3 years which allows the authors to offer some countermeasures and new advices to improve the drug administration work.