Analysis on the Unannounced Inspection of GMP(2010) in Pharmaceutical Enterprises

OBJECTIVE To know more about the rules and characteristics of defects on unannounced inspection of the GMP(2010) on pharmaceutical enterprises, to provide reference and measures for supervision department. METHODS Analyzing the defects found in the unannounced inspection of 11 pharmaceutical enterprises organized by Guangxi Food and Drug Evaluation & Inspection Center in 2017. RESULTS Eleven pharmaceutical enterprises accepted unannounced inspection and 4 of them were deprived of GMP certificates. A total of 6 major deficiencies were found:enterprises failing to approve prescription technology to organize production, personnel's training was affirmed to be insufficient, material and products management was ineffective, production management was nonstandard, quality control and quality assurances was poor and data was not reliable. CONCLUSION The enterprises shall innovate themselves, update their concepts, improve the GMP system. The supervision department shall change and innovate the regulatory thinking, to improve the deterrentness and authority of unannounced inspection, and encourage pharmaceutical enterprises to continuously implement the GMP.