从FDA警告信,看数据可靠性  

From The FDA's Warning Letter to See The Data Integrity

作　　者：胡敬峰 韩莹[1] 

机构地区：[1]山东省食品药品监督管理局审评认证中心,山东济南250013

出　　处：《中国医药工业杂志》2017年第9期1390-1393,共4页Chinese Journal of Pharmaceuticals

摘　　要：警告信是美国FDA对被检查企业存在严重违规事实所采取的一种监管手段。2016年FDA发布药品cGMP警告信数量显著增加,数据可靠性问题也愈发凸显。为了把握FDA药品cGMP检查的数据可靠性关注重点,了解药品生产数据可靠性国际检查趋势,本文统计了2012~2016年FDA对国外企业发布的125封药品cGMP警告信,重点解析63封涉及数据可靠性问题的警告信,归纳分析数据可靠性缺陷项目。结果表明数据可靠性成为近年cGMP检查的关注重点,计算机化系统的权限控制、记录管理和实验室控制是数据可靠性问题集中的3个方面。企业应把握数据可靠性的检查方向,增强数据管理的规范性,提升数据的可靠性。Warning letter is a regulatory tool adopted by the FDA for the existence of serious violations of the enterprise being inspected. The number of FDA＇s cGMP warning letters increased dramatically in 2016, data integrity issues have become increasingly noticeable. In order to grasp the focus of data integrity in FDA＇s cGMP inspection, understand the trend of international inspection of data integrity in drug production, 125 FDA＇s cGMP warning letters issued to foreign enterprises from 2012 to 2016 should be analyzed statistically, focusing on analyzing 63 warning letters related to the data integrity issues, and summarizing the data integrity defects in the warning letters. The results show that data integrity became the focus of cGMP inspection in recent years. Authority control of computerized system, record management and laboratory control are the top three aspects of data integrity problems. Enterprises should grasp the inspection direction of data integrity, further standardize the data management, and enhance the integrity of data.

关 键 词：美国食品药品监督管理局 药品 现行药品生产质量管理规范 数据可靠性 警告信 

分 类 号：R95[医药卫生—药学]