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In accordance with the requirements of the provincial bureau, the head of the eighth branch of the team on the provincial drug review and inspection center on November 6-8, 2020 huangshan Guangyingtang Chinese Medicine Co., Ltd. to carry out the drug GMP compliance inspection and provincial bureau Of Chinese medicine On December 3-4, 2020, the Cosmetic Supervision Department conducted a flight inspection of Anhui Xiangyungu Modern Chinese Medicine Co., Ltd. and conducted a collective interview with the legal representative and quality person in charge and the quality antr of the two pharmaceutical production enterprises mentioned above.
interview meeting, the eighth branch of the inspection of two pharmaceutical production enterprises found missing items and the implementation of rectification requirements, stressed the importance of drug quality and safety awareness, requiring enterprises to effectively fulfill the main responsibility of drug quality and safety, strengthen contact and communication with regulatory authorities, do a good job of rectification, and comprehensively improve the quality management capacity and level of pharmaceutical production.
Interview requirements: First, enterprises are required to strictly implement the main responsibility of drug quality and safety, seize the outstanding problems in drug production and quality management, carefully comb the quality management system, find the right risk points, take the initiative to carry out risk prevention and control, to ensure drug quality and safety; Third, enterprises are required to strengthen the awareness of quality management from the top down, improve the level of quality management, increase the newly revised Drug Management Law, drug production supervision and management measures (enacted in 2020) and other training efforts to put quality management into practice;
next step, the 8th Bureau will urge enterprises to comprehensively investigate the hidden dangers of drug production quality and safety risks, through effective rectification to ensure the effective operation of the quality management system, to ensure the safety and effective quality of drugs.
source: Anhui Provincial Drug Administration