【摘要】：警告信是美國FDA對被檢查企業(yè)存在嚴重違規(guī)事實所采取的一種監(jiān)管手段。2016年FDA發(fā)布藥品cGMP警告信數(shù)量顯著增加,數(shù)據(jù)可靠性問題也愈發(fā)凸顯。為了把握FDA藥品cGMP檢查的數(shù)據(jù)可靠性關注重點,了解藥品生產數(shù)據(jù)可靠性國際檢查趨勢,本文統(tǒng)計了2012~2016年FDA對國外企業(yè)發(fā)布的125封藥品cGMP警告信,重點解析63封涉及數(shù)據(jù)可靠性問題的警告信,歸納分析數(shù)據(jù)可靠性缺陷項目。結果表明數(shù)據(jù)可靠性成為近年cGMP檢查的關注重點,計算機化系統(tǒng)的權限控制、記錄管理和實驗室控制是數(shù)據(jù)可靠性問題集中的3個方面。企業(yè)應把握數(shù)據(jù)可靠性的檢查方向,增強數(shù)據(jù)管理的規(guī)范性,提升數(shù)據(jù)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.
【作者單位】： 山東省食品藥品監(jiān)督管理局審評認證中心;
【分類號】：R95
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本文編號：2474397