Notice of the general office of the food and Drug Administration on strengthening the quality supervision of biochemical drugs

Source: CFDA 2015-6-18 SFDA [2015] No.79 food and Drug Administration of all provinces, autonomous regions and municipalities directly under the central government, food and Drug Administration of Xinjiang production and Construction Corps: June 17, 2015 On December, the State Food and Drug Administration issued the circular on illegal production of calf blood deproteinized extract injection by Wuhan Hualong biopharmaceutical Co., Ltd (2015 No 21, hereinafter referred to as the circular) The food and Drug Administration of each province (district or city) shall earnestly implement the tasks proposed in the circular The notice of relevant requirements is as follows: first, the General Administration of food and Drug Administration of Hubei Province has asked the food and Drug Administration of Hubei Province to urge Wuhan Hualong biopharmaceutical Co., Ltd to recall all the market calf blood deproteinized extract injection immediately The food and Drug Administration of each province (district or city) shall immediately notify the drug distributors and users within its administrative region to stop selling and using the calf blood deproteinized extract injection produced by Wuhan Hualong biopharmaceutical Co., Ltd., and assist in recalling the products II The food and Drug Administration of Liaoning, Jilin, Heilongjiang, Shanghai, Anhui, Hubei, Hunan, Guangdong, Chongqing and other provinces (cities) shall, in accordance with the requirements of the circular, produce calf blood protein free extract injection, calf serum protein free injection, calf blood protein free extract for injection, calf blood protein free extract for injection, sodium chloride injection, etc in the administrative region The manufacturer of the product shall conduct a comprehensive inspection First of all, enterprises should conduct self inspection Those who purchase intermediate products and fail to produce according to the approved process and standards must stop production and sales immediately and recall the products on the market The enterprise self inspection report shall be submitted to the local provincial food and drug administration before June 20 The above-mentioned provincial (municipal) bureaus shall, on the basis of enterprise self inspection, carry out special inspection on the enterprise, and submit the inspection situation and the on-site inspection report signed and endorsed by the inspectors to the general administration before June 25, 2015 3 The food and Drug Administration of each province (District, city) shall attach great importance to the quality and safety of biochemical drugs We should organize forces to carry out a comprehensive inspection of biochemical drug manufacturers in our administrative region, focusing on the supply channels of raw materials, production processes and quality control, take effective measures to control risks in time for quality problems found, and strictly investigate and deal with illegal behaviors such as unauthorized change of processes and purchase of extracts Please report the inspection to the general administration before June 30 General Office of food and Drug Administration June 17, 2015