从FDA警告信,看数据可靠性
发布时间：2019-05-11 09:56
【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。
[Abstract]:Warning letter is a kind of regulatory means adopted by FDA in the United States to regulate the existence of serious violations by the inspected enterprises. The number of drug cGMP warning letters issued by FDA in 2016 has increased significantly, and the problem of data reliability has become more and more prominent. In order to grasp the key points of data reliability of FDA drug cGMP inspection and understand the trend of international inspection of drug production data reliability, this paper counts 125 cGMP warning letters issued by FDA to foreign enterprises from 2012 to 2016. 63 warning letters related to data reliability are analyzed, and the items of data reliability defects are summarized and analyzed. The results show that data reliability has become the focus of cGMP inspection in recent years. The authority control of computerized system, record management and laboratory control are the three aspects of data reliability problem concentration. Enterprises should grasp the inspection direction of data reliability, enhance the standardization of data management, and improve the reliability of data.
【作者单位】： 山东省食品药品监督管理局审评认证中心;
【分类号】：R95
，
本文编号：2474397
[Abstract]:Warning letter is a kind of regulatory means adopted by FDA in the United States to regulate the existence of serious violations by the inspected enterprises. The number of drug cGMP warning letters issued by FDA in 2016 has increased significantly, and the problem of data reliability has become more and more prominent. In order to grasp the key points of data reliability of FDA drug cGMP inspection and understand the trend of international inspection of drug production data reliability, this paper counts 125 cGMP warning letters issued by FDA to foreign enterprises from 2012 to 2016. 63 warning letters related to data reliability are analyzed, and the items of data reliability defects are summarized and analyzed. The results show that data reliability has become the focus of cGMP inspection in recent years. The authority control of computerized system, record management and laboratory control are the three aspects of data reliability problem concentration. Enterprises should grasp the inspection direction of data reliability, enhance the standardization of data management, and improve the reliability of data.
【作者单位】： 山东省食品药品监督管理局审评认证中心;
【分类号】：R95
，
本文编号：2474397
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