中美两国药品GMP合规检查信息及相关数据库的比较研究
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篇名: 中美两国药品GMP合规检查信息及相关数据库的比较研究
TITLE:
摘要: 目的:为进一步完善我国药品生产管理规范(GMP)合规检查信息及相关数据库的建设提供参考。方法:汇总中美两国药品监管部门相关网站上关于药品GMP合规检查的相关信息,从检查报告格式及内容、年度报告和数据库建设等方面进行比较分析,对我国药品检查信息及相关数据库的完善提出建议。结果与结论:我国国家药品监督管理局的合规检查信息及数据库功能与美国FDA相比存在较大差距。对于药品GMP合规检查信息,美国FDA建有比较专门的数据库,并具有高级检索功能,便于公众使用检索信息;而目前我国数据库专栏并不完善,只能按序浏览,几乎不具备检索功能,并非真正意义上的信息数据库。美国FDA在药品GMP合规检查信息内容中,对缺陷的阐述、给企业提供的建议或帮助及关键数据的保密等措施都较为科学和人性化,且公布较为及时;而我国食品药品审核查验中心发布的与药品GMP合规检查相关的飞行/跟踪检查通报内容详细程度略差,缺陷归类划分不明晰,从检查结束到通报发布的周期较长。建议我国药品GMP合规检查信息及数据库功能应从扩大药品GMP检查信息收录种类及范围、完善检索功能、提供数据库配套使用说明书、细化报告内容等方面进行完善。
ABSTRACT: OBJECTIVE: To provide reference for further improving China’s Good Manufacturing Practice (GMP) compliance inspection information and the construction of related database. METHODS: The relevant information on drug GMP compliance inspections from the websites of drug administration departments in China and America were collected, compared and analyzed from the aspects of the format and content of inspection report, annual report and database construction. The suggestions were put forward for the improvement of China’s drug inspection information and related databases. RESULTS & CONCLUSIONS: There was a large gap in the compliance inspection information and database functions between China NMPA and US FDA. For the drug GMP compliance inspection information, US FDA had established a special database to facilitate the public to use the search information, and had advanced search capabilities. At present, the database in China was not perfect and not a true meaningful database. It can only be browsed in order, and had almost no search function. In the content of drug GMP compliance inspection information, US FDA had made scientific and humanized measures for the description of defects, the advice or assistance provided to enterprises, and the confidentiality of key data, and the publication was timely. The details of the flight/tracking inspection notifications related to drug GMP compliance inspection issued by China CFDI were slightly poorer, and the classification of defects was not clear. The period from the end of the inspection to the release of the notification was longer. It is suggested that China’s drug GMP compliance inspection information and database functions should be improved from expanding the types and scope of GMP inspection information, improving the search function, and providing database instruction manual and refining the report content.
期刊: 2019年第30卷第22期
作者: 申琦,李年苏,梁毅
AUTHORS: SHEN Qi,LI Niansu,LIANG Yi
关键字: 药品生产管理规范;合规检查;信息;数据库;中国;美国;比较
KEYWORDS: Good Manufacturing Practice; Compliance inspection; Information; Database; China; America; Comparison
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