中国药物经济学2019,Vol.14Issue(2):38-42,65,6.DOI:10.12010/j.issn.1673-5846.2019.02.006
基于2016—2017年数据的药品飞行检查分析
Analysis of Unannounced Inspection of Drugs Based on Date in 2016 and 2017
李年苏 1梁毅1
作者信息
- 1. 中国药科大学国际医药商学院, 江苏南京 211198
- 折叠
摘要
Abstract
Objective To make an analysis on information of unannounced inspection of drugs published by China Food and Drug Administration (CFDA) in 2016 and 2017, so as to help drug production enterprises to find their own defects effectively and implement Good Manufacturing Practice (GMP) better. Methods The content of unannouced inspection of drugs released in 2016 and 2017, such as the information of releasing time, inspection time, enterprise situations, relative products, reasons and problems, was analysed by browsing the website of CFDA and retrieving unannounced inspection of drugs from the "Special Column".Results and Conclusion Although the unannounced inspection of drugs is flexible in form, it has definite features and rules.关键词
药品飞行检查/药品生产质量管理规范/统计分析Key words
Unannounced inspection of drugs/GMP/Statistics and analysis分类
医药卫生引用本文复制引用
李年苏,梁毅..基于2016—2017年数据的药品飞行检查分析[J].中国药物经济学,2019,14(2):38-42,65,6.