A medical enterprise is put on file, CFDA issues a document to warn all enterprises

Source: sepilan 2016-09-19 yesterday (September 18), the State Food and Drug Administration issued two announcements One is the report on the flight inspection of Jilin Changyuan Pharmaceutical Co., Ltd and the other is the news that the GMP certificate of Changyuan Pharmaceutical Co., Ltd has been withdrawn It is extraordinary that the State Administration issued a separate message after the flight inspection notification, which shows the importance of the national administration on this incident Through this unusual move, the State Administration would like to convey and emphasize that this flight inspection is a warning and spur to the whole industry, especially the biochemical drug production enterprises What is the warning and spur? Enterprises, raw materials and accessories can not be ignored ah! The focus of this investigation is biochemical medicine, and it is also biochemical medicine enterprises that fall down However, for the whole industry to receive raw materials and auxiliary materials, we must pay attention to them The National Bureau has sounded the alarm, and once again, we must not ignore them! What needs to be done? The State Administration also made it clear in the press release that it strengthened supplier audit and supply chain management On September 18, the enterprise was put on file The State Food and Drug Administration issued a notice During the flight inspection, it was found that Jilin Changyuan Pharmaceutical Co., Ltd violated the drug administration law of the people's Republic of China and relevant provisions of GMP in the production of naopeptide capsule and compound cerebroprotein hydrolysate tablets, and decided to seal up the drugs in stock and recover the GMP of the enterprise Certificate, order to recall the products already sold, and put on record and investigate the illegal production behavior of the enterprise A spokesman for the State Food and Drug Administration pointed out that at present, there are some problems in the supply chain management of raw and auxiliary materials in some biochemical drug enterprises On the one hand, it is necessary to speed up the research and formulation of relevant production specifications; on the other hand, it is necessary to further strengthen the supervision and inspection to further urge the enterprises to continue to produce in compliance with the regulations Biochemical pharmaceutical enterprises must attach importance to the audit of upstream raw and auxiliary material suppliers, strengthen supply chain management, and effectively assume the main responsibility for drug quality During the random inspection, it was found that according to the work plan, in the middle of June, when the General Administration organized the inspection center to carry out random inspection on biochemical drugs, it was found that the ingredients extracted by a production enterprise also flowed to drug manufacturers such as Jilin Changyuan Pharmaceutical Co., Ltd., and the general administration immediately decided to carry out extended inspection After the flight inspection of the brain peptide capsule and compound brain protein hydrolysate tablet produced by the company, it was found that the enterprise had some illegal behaviors, such as changing the extraction process of pig brain, making up records, using pig brain dry residue directly without authorization, etc., which violated the drug administration law of the people's Republic of China and the relevant provisions of GMP The general administration requires the Jilin food and drug administration to supervise the enterprises to seal the brain peptide capsules in stock, take back the GMP certificate of the enterprises, order the enterprises to recall the products they have sold, and put on record the illegal production behaviors of the enterprises for investigation Only Changyuan Pharmaceutical Co., Ltd of Jilin Province was disclosed this time However, according to the statement of the State Administration, there should be other enterprises, and the flow direction is not only this one In recent years, most enterprises have strengthened the quality control of raw and auxiliary materials, supplier audit and supply chain management However, some pharmaceutical enterprises did not pay enough attention to the management of raw and auxiliary materials, and the audit of suppliers went through the field without establishing a real supply chain quality control system What's more, in order to save the cost of raw materials, there are some problems, such as changing the process, recording fraud, illegal feeding and so on This flight inspection is a warning and spur to the whole industry, especially the biochemical drug manufacturers This year, 10 pharmaceutical enterprises were received GMP due to raw and auxiliary materials According to the notice on flight inspection issued by the State Food and drug administration, this year, the State Food and Drug Administration issued a total of 19 notices on flight inspection of pharmaceutical enterprises, of which 10 were disclosed that there were problems with raw and auxiliary materials, accounting for more than half It can be seen that the problem of raw and auxiliary materials has become a high incidence problem, and it is understandable that the National Bureau specially issued a notice on it The following is a list of enterprises and reasons that have received GMP certificate due to the problems of raw and auxiliary materials As for the possible problems of raw and auxiliary materials, enterprises can conduct self inspection, timely adjust and strive to achieve compliance.