摘要
目的对2016年和2017年国家食品药品监督管理总局(CFDA)发布的药品飞行检查信息进行分析和统计,从而帮助药品生产企业有效地查找自身缺陷,更好地实施药品生产质量管理规范(GMP)。方法浏览CFDA网站,查阅专题专栏项下的飞行检查内容,对2016年和2017年发布的药品飞行检查数据,如发布时间、检查用时、企业及产品种类、检查事由和发现问题等进行统计分析。结果与结论飞行检查虽然在形式上灵活机动,但是有明确的特征和规律可循。
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.
作者
李年苏
梁毅
LI Nian-Su;LIANG Yi(School of International Medicine,China Pharmaceutical University,Nanjing 211198,China)
出处
《中国药物经济学》
2019年第2期38-42,65,共6页
China Journal of Pharmaceutical Economics
作者简介
通信作者:梁毅,E-mail:ly606@sohu.com.
