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.
出处
《中国药事》
CAS
2016年第9期858-865,共8页
Chinese Pharmaceutical Affairs
关键词
药品抽验
风险评估
药品类别
检验项目
不合格分析
drug sampling analysis
risk assessment
drug category
test items
OOS analysis
