Problem Analysis and Regu latory Countermeasures of Unannounced Inspection and Tracking Inspection of 28 Pharmaceutical Manufacturers / 中国药房

ABSTRACT

OBJECTIVE： To provide reference for pharmaceutical manufacturers improving the quality system of GMP and drug regulatory departments improving their supervision level. METHODS： Through analyzing and summarizing the problems existing in the 28 pharmaceutical enterprises which had been published on the website in the National Medical Products Administration from February 6th， 2018 to January 25th， 2019， the common problems were found and their causes were analyzed， then the regulatory countermeasures were put forward. RESULTS & CONCLUSIONS： Pharmaceutical enterprises have some problems of inadequate implementation of GMP， such as the inadequate performance of personnel in key positions and the unsatisfactory training effect of relevant personnel， the inconsistency between actual production technology and approved legal technology， the non-standard management of enterprise materials， the incomplete batch production records and the inability to effectively monitor the production cycle. However， there are also some problems in the supervision department， such as the large difference in the scale of inspectors’ on-site inspection， the need to strengthen the inspectors’ inspection ability and level， and the lack of innovation in the means of supervision. It is suggested that pharmaceutical manufacturers should improve the construction of GMP quality management system and strengthen the training of relevant personnel； the regulatory authorities should continue to promote the reform of “release， control and service”， strictly enforce the access conditions of inspectors， strengthen the training of inspectors and ideological construction of the inspector team，further strengthen the construction of supervision system and enhance the innovation of supervision means， so as to jointly maintain the safety， effectiveness and quality controllability of medicines.