优化风险评估方式提高抽验工作效能  

Improvement of the Drug Random Inspection Efficiency by Optimizing Risk Assessment Mode

作　　者：车宝泉[1] 杨文良[1] 

机构地区：[1]北京市药品检验所,北京100035

出　　处：《中国药事》2016年第9期858-865,共8页Chinese Pharmaceutical Affairs

摘　　要：目的:探讨在药品抽验工作中如何以风险评估为基础,强化检验靶向性,提高检验效率,服务监管工作。方法:统计了抗生素、生化药品、中成药等类别的13万件药品出现的不合格情况,进行不合格项目分析。结果:共统计了649个检验项目,其中84个项目出现过不合格,不同类别出现频次较高的不合格项目各有特点。结论:通过开展以风险为导向,进行关键项目抽查检验的方式同样能够发现问题样品,研究结果可供药品抽验工作参考。Objective： To explore the use of risk assessment mode in the drug sampling analysis for quality evaluation. Methods： Out of specification（OOS） items in 130,000 samples were analyzed by different drug categories（Antibiotics, Biochemical drug, Chinese traditional medicine, etc.）. Results： A total of 84 OOS items were found in the 649 test items, but OOS did not occur in many items, such as arsenic salt, disintegration and so on. However, characteristic OOS items occurred with relatively high frequency in different categories of drugs.Conclusion： The use of risk assessment mode in the drug key items analysis for quality evaluation can provide an effective way in improving the inferior drugs target hit rate. Furthermore, the results are conductive to optimized development of supervision efficiency.

关 键 词：药品抽验 风险评估 药品类别 检验项目 不合格分析 

分 类 号：R954[医药卫生—药学]