The General Administration informed three drug manufacturing enterprises of flight inspection and recalled the GMP certificates of two enterprises

Source: CFDA April 18, 2016, the State Food and Food Administration reported the flight inspection of three drug manufacturers Order to take back the GMP certificates of the two enterprises, and investigate the illegal behaviors of the three enterprises I The food and Drug Administration of Guizhou Shouxian Pharmaceutical Co., Ltd found in the flight inspection of Guizhou Shouxian Pharmaceutical Co., Ltd that the enterprise continued to illegally produce drugs after the expiry of the GMP certificate; changed part of the product batch number; suspected of counterfeiting production records, inspection records and material records; suspected of Jerry building; material management confusion and other issues Guizhou Shouxian Pharmaceutical Co., Ltd.'s mixture GMP certificate is valid until June 9, 2015 After expiration, it continues to illegally produce 9 batches of Xiangyu Weishu mixture without certification The enterprise selects the returned products without leakage for repacking, and changes the three batches of returned products of Xiangyu Weishu mixture into two production batches for sale In the "pretreatment process record" and "extraction and concentration process production record" of Andrographis paniculata decoction pieces, there are three completely different handwriting in Qin's signature of the operator of the enterprise, with obvious forgery traces The enterprise does not have the full inspection conditions for frankincense, Radix Pseudostellariae and Andrographis, but the enterprise inspection report shows that the full inspection has been carried out According to the financial invoice provided by the enterprise, there is a big difference between the purchase amount of relevant medicinal materials and the storage amount of medicinal materials and the production and feeding amount The second floor warehouse of the enterprise's extraction workshop is used to store a variety of Chinese herbal medicines, such as chrysanthemum, phellodendron, mirabilite, frankincense, dandelion, honeysuckle, Andrographis, etc., some of the packages of Chinese herbal medicines have been damaged, a large number of herbal medicines are scattered on the ground, all of the materials have no corresponding location cards, and there is no information such as origin, source, purchase date, inspection status, etc on the material identification The data of some kinds of inner packing and label instruction books, cards and materials in the packaging material warehouse of the enterprise are seriously inconsistent In response to the problems found in the inspection, the food and Drug Administration of Guizhou Province requires the food and Drug Administration of Guizhou Province to supervise Guizhou Shouxian Pharmaceutical Co., Ltd to seal its inventory products, order the enterprise to recall the sold products, and put the serious illegal production behavior of the enterprise on file for investigation and handling II During the flight inspection of Hebei Yongfeng Pharmaceutical Co., Ltd of Shiyao group, it was found that the enterprise was suspected of using fake and inferior medicinal materials or cutting corners; changing the sterilization process of intermediate products without authorization; and the inspection record of original medicinal materials was not authentic The inspectors took aloe samples from the site of Hebei Yongfeng Pharmaceutical Co., Ltd for inspection, and no aloin was detected by TLC In the absence of research and evaluation on the impact of irradiation sterilization on product quality, from 2013 to 2014, the enterprise changed the wet heat sterilization of traditional Chinese medicine powder directly used in medicine to 60go - γ - ray irradiation sterilization without change control record The enterprise has signed an irradiation agreement with Baoding nuclear power source irradiation Co., Ltd., and the quality terms have no clear requirements for parameters such as irradiation loading mode, time, dose, etc., and no complete sterilization process control documents and sterilization records have been established The irradiation sterilization of gentian powder is in violation of the technical guidelines for irradiation sterilization of traditional Chinese medicine From 2013 to 2015, seven batches of raw Scutellaria were purchased, and the original inspection records of these seven batches were obtained It was found that the atlas of two batches of raw Scutellaria was highly consistent with the atlas of the other two batches of Scutellaria, suspected of modifying the time and applying the atlas The General Administration of food and drug administration requires the food and Drug Administration of Hebei Province to immediately take back the relevant GMP certificate of Hebei Yongfeng Pharmaceutical Co., Ltd of Shiyao group, order the enterprise to stop production, investigate the production and sales of Tongqiao deafness pill, recall all products on sale, and carry out case investigation III Gansu dadelli Pharmaceutical Co., Ltd found that Gansu dadelli Pharmaceutical Co., Ltd had serious non-compliance with the GMP in the GMP follow-up inspection organized by the food and drug inspection center of the food and drug administration The main defects are lack of quality assurance measures for main raw materials and high quality risk; inadequate production management and necessary process control; inadequate quality management and lack of key control items, etc the production of thymosin products has high risk Gansu Dadeli Pharmaceutical Co., Ltd does not specify the species, source and specific age of production calves; does not investigate the breeding environment of cattle, and cannot determine the health impact of the breeding environment on cattle; does not specify the mode of transportation of calf thymus, the storage period after collection; does not specify the inspection requirements for animal quarantine certificate The production of thymosin did not carry out the verification of virus inactivation / removal and heat change according to the technical requirements of multi-component biochemical drugs; and did not set the process time limit of different processes according to the characteristics of multi-component biochemical drugs There are no necessary safety control items such as bacterial endotoxin or pyrogen in the internal control quality standard of thymosin solution; the content, activity (activity) and yield of active components of thymosin product are not verified by methodology; the deviation management is not effectively implemented, and the deviation account has no content The food and drug administration requires the food and Drug Administration of Gansu Province to take back the GMP certificate of Gansu dadili Pharmaceutical Co., Ltd., supervise the recall of all thymosin products on the market and carry out case investigation.