关键词: 缺陷项目整改, 风险管理, 整改闭环, 整改报告

Abstract:

The improvement of quality management system is a gradual and continuous process. The continuous improvement of quality management system in drug distribution enterprises cannot be separated from the supervision of drug regulatory departments， and the effective rectification of defect items found in the supervision process by drug distribution enterprises. At present， NMPA has not issued relevant guidance documents for drug distribution enterprises on how to complete the rectification of defective items found during the inspection of drug regulatory departments in a scientific， standardized， effective and high-quality manner. On the basis of sorting out the basic concepts and principles of the rectification of defect items， combined with practical experience， and under the guidance of risk management concept， this study discussed the steps and requirements of the rectification of defect items in drug distribution enterprises， expounded the key points of writing rectification report， and summarized the common problems existing when rectification was not in place， so as to provide reference for the systematic， effective and scientific rectification of the defect items found by drug regulatory departments in the inspection. It is suggested that drug distribution enterprises should implement the main responsibility of the enterprise according to the concept of risk management and the actual situation of the enterprise， complete the rectification of defective items scientifically， effectively and systematically with the participation of all staff， so as to prevent the occurrence of major problems such as violations of laws and regulations， reduce errors in all aspects， ensure the safety and effectiveness of the drug， and ensure the orderliness， legality and compliance of drug distribution.

Key words:  , Defect item rectification； , Risk management； , Closed-loop rectification closed-loop； , Rectification report