Dazhou: 45 pharmaceutical enterprises in "two dozen and two construction"

Since the Municipal Food and Drug Administration launched the special action of "two dozen and two construction" in the production link of drugs, it has earnestly implemented the work deployment of the National Bureau and the Provincial Bureau, closely focused on the target task of cracking down on illegal drug production, strengthened organizational leadership, strengthened responsibility implementation, and focused on publicity and training At present, remarkable results have been achieved in the special action of "two strikes and two constructions" in the pharmaceutical production link of our city The bureau takes the production enterprise of Chinese herbal pieces as the key point of "two dozen and two construction", focusing on the inspection of the purchase and inspection of raw and auxiliary materials, the implementation of production technology and quality standards, the inspection of finished products, and whether there is affiliation and OEM production The bureau strengthens the quality awareness of key personnel in the enterprise Hold meetings of legal person and quality director of drug manufacturing enterprises in the jurisdiction for many times, arrange work tasks, and strengthen the awareness that the enterprise is the first person responsible for quality At the same time, the flight inspection shall be strengthened, and the enterprises with many product non conformity reports and product quality problems shall be taken as the focus of flight inspection, and the problems found in flight inspection shall be filed for investigation Key inspection was carried out on the production of traditional Chinese medicine extracts, and no illegal production behavior was found The bureau also pays attention to legal publicity and strengthens the management of enterprise personnel In view of the current situation of drug manufacturing enterprises, such as a wide range of points, fierce market competition, large employee mobility and unstable team, the Bureau has organized five training meetings for key personnel (legal person, quality director and quality authorizer) of the enterprise, with a total of more than 1300 trainees, which effectively strengthened their awareness of knowing the law and abiding by the law, and ensured the drug safety produced At the same time, in order to strengthen the management of key personnel in the enterprise, statistics have been made on the production director, quality director, QA and QC personnel of the enterprise, and key personnel files have been established, totaling 760 to ensure that personnel qualification, education background and specialty meet the requirements Since the special action of "two strikes and two constructions" was carried out, the Bureau has inspected 140 pharmaceutical production enterprises, ordered 45 rectification, ordered 6 production suspension and rectification, actively applied for 6 production suspension and rectification, temporarily controlled 4 GMP certificates and recovered 1 GMP certificate.