[note] the State Food and drug administration has withdrawn 5 GMP sheets, all of which are commonly used drugs

Recently, six companies were tracked and inspected by the State Food and drug administration It was found that the six companies had serious violations in the material production process, and the GMP certificates of the related drugs of five companies were withdrawn according to law Guizhou Deliang baishite Pharmaceutical Co., Ltd was required not to resume production until the rectification was completed Specifically, the following 6 companies highlighted problems in the inspection Five pharmaceutical companies were withdrawn GMP certificates of related drugs, one required to stop production and rectify the inspection products of Jiangsu 707 Natural Pharmaceutical Co., Ltd.: Chenxiang chemical gas pill 1 The material management was not standardized, some of them were not marked, which could not ensure the prevention of pollution and the correct storage and delivery of materials 2 It can not effectively prevent the confusion of production and operation process 3 Some deviations were not investigated Bizhigao Pharmaceutical Co., Ltd inspection products: Jieyu Anshen granules 1 Process validation 1) The quality and stability of Jieyu Anshen granules with batch numbers of 20130902, 20140201 and 20140202 were not evaluated (the announcement shows that the batch number of products changed to 200000 bags in July 2015) 2) the storage time limit of Jieyu Anshen granules dry paste powder (the storage time limit specified by the enterprise is 6 months, and it can be stored for another 6 months after the retest) was not verified 2 Data management and documentation 1) The enterprise did not take preventive measures to prevent data deletion from happening again 2) Some batch inspection result items in the inspection account of traditional Chinese medicine are blank, and the batch information of some traditional Chinese medicine in the inspection account is inconsistent with the corresponding information in the raw and auxiliary materials account 3 Processing of Chinese herbal pieces 1) The processing procedures and batch range of Chinese herbal pieces have not been formulated The production records of zhiyuanzhi (batch No.: j160101, batch No.: 179.6kg; j160102, batch No.: 19.6kg) show that the calculation of drying, Decoction and auxiliary materials are inconsistent with the requirements of Pharmacopoeia Products inspected by Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd.: cefotaxime hydrochloride for injection 1 Containers directly contacting with drugs are not approved and verified for production of some batches of products During the inspection, the company has launched a recall procedure to recall two batches of products 2 The characteristics of the products are not fully studied, the data analysis is not comprehensive, and the production quality management of cefotaxime hydrochloride for injection is not perfect 3 In some processes, the suspended particles in the clean area were not monitored dynamically as required Inspection products of Guizhou Deliang Pharmaceutical Co., Ltd.: Xiaoyan Zhike capsule 1 Safety management of special drugs does not meet the requirements of special drug laws and regulations 2 The computerized system does not meet the requirements (ultraviolet spectrophotometer, high performance liquid chromatograph, gas chromatograph, atomic absorption spectrophotometer and other optical instruments do not meet the requirements.) 3 Quality control and quality assurance do not meet the requirements 4 Problems in validation and validation 1) The main issues involved in the announcement are that the sharing feasibility of the attributes of baihuacao capsule, Ganoderma lucidum capsule, poppy shell and ephedra has not been evaluated 2) the sterilization method of Xiaoyan Zhike capsule has not been evaluated to have an impact on the product 5) data reliability 6 There are three general defects in organization, personnel, equipment and production management Guizhou Deliang baishite Pharmaceutical Co., Ltd 1 Special drug safety management does not meet the requirements of special drug laws and regulations 2 The management of quality control laboratory is not standard 3 The computerized system does not meet the requirements 4 There are three general defects in organization and personnel, confirmation and verification, and commissioned production Inspection products of Shanghai anding biological (Tangyin) Pharmaceutical Co., Ltd.: Ankahuangmin capsule and paracetamol Kamin granule 1 Relevant work has not been completed in full accordance with the requirements of the supplementary application for drugs 2 The enterprise did not evaluate and investigate the quality risk 3 Laboratory data management is not standardized 4 Control article management is not standardized What is the market situation of recovered 5 drugs? Accession Chenxiang Huaqi pill: up to now, the product has been produced by 20 enterprises, and the outgoing source of Jiangsu 707 Natural Pharmaceutical Co., Ltd.: the domestic drug database Chenxiang Huaqi pill is mainly used for regulating qi and liver, eliminating accumulation and stomach It is used for stagnation of liver and stomach qi, abdominal distention and pain, fullness of chest, diaphragms and ruffles, not thinking about diet, belching and pantothenic acid According to the bidding database of Yaozhi, the latest bid price is 11.4 yuan (1.75g per 10 pills; bid winning enterprise: Lanzhou foci Pharmaceutical Co., Ltd.) I think it is a small variety in the market, but it is a commonly used Chinese patent medicine for patients with spleen and stomach discomfort Accession Jieyu Anshen granules: at present, there are 31 manufacturers in production Bizhigao Pharmaceutical Co., Ltd is out of the market source: domestic drug database of Yaozhi, according to the instructions of Yaozhi drugs, Jieyu Anshen granules are mainly used to soothe the liver and relieve the depression, and calm the mind and set the mind It is used for insomnia, upset, anxiety, forgetfulness, neurosis and climacteric syndrome caused by poor mood and stagnation of liver qi According to the database of the highest retail price of smart drugs, the highest one-time price of Jieyu Anshen granules was 78 yuan (specification: 5g × 8 bags × 2 boxes; pricing area: Hainan; pricing enterprise: Qinhuangdao Huangwei pharmaceutical factory) This product is loved by most enterprises that develop traditional Chinese medicine preparation According to the registration and acceptance database of pharmaceutical intelligence, 12 pharmaceutical companies applied for the production of the drug from 2005 to 2006 In the end, Ma'anshan shenlu Kerui pharmaceutical, Tonghua Zhenlin pharmaceutical, Heilongjiang gerun pharmaceutical and Chengdu Senke pharmaceutical obtained the production license, while Harbin Yizhou pharmaceutical and Beijing Yadong bio pharmaceutical of Yuanda Pharmaceutical Group obtained the generic drug Production license Accession Cefotaxime hydrochloride for injection: 10 companies produce the product, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd outgoing source: domestic drug database of pharmaceutical intelligence Cefotaxime hydrochloride for injection is suitable for many kinds of infections caused by Streptococcus (except Enterococcus), Streptococcus pneumoniae, Enterococcus, Streptococcus Alimentarius, Escherichia coli, Citrobacter, Klebsiella, enterobacter, Serratia, proteus, Haemophilus influenzae and Bacteroides which are sensitive to cefotaxime According to the database of drug registration and acceptance, 103 acceptance numbers are involved in the undertaking of the product, including 23 new drug applications and 41 generic drug applications Up to now, there are 68 acceptance numbers showing "certificate preparation completed - approved documents" and 7 acceptance numbers with the final review conclusion of "approved production", which are respectively included by Guangzhou Baiyunshan Tianxin pharmaceutical, Liaoning HISCO pharmaceutical, Henan Shuaike pharmaceutical, Jilin Huinan Changlong biochemical pharmaceutical and Hainan Lingkang pharmaceutical Now Tianxin Pharmaceutical Co., Ltd in Baiyunshan, Guangzhou is out of the market The market of this product is temporarily shared by four other pharmaceutical companies Accession Xiaoyan Zhike capsule: it is only produced by Guizhou Deliang Fang baisite Pharmaceutical Co., Ltd in China, and now it is mainly used for anti-inflammatory, antitussive, expectorant and asthma It is used for coughing and phlegm, chest full of Qi, and tracheitis According to the announcement database of pharmaceutical intelligence drug quality nonconformity, the product (due to the difference of loading capacity) produced by Guizhou Deliang baishite Pharmaceutical Co., Ltd has been registered in the third issue of Jiangxi drug quality announcement and the first issue of Guizhou drug inspection nonconformity quality announcement 2016 on September 10, 2015 and July 19, 2016 According to the drug registration and acceptance database, Xiaoyan Zhike capsule has been approved by six pharmaceutical enterprises, including Harbin Pharmaceutical Group Sanjing Pharmaceutical Co., Ltd Nuojie and Guizhou Shouxian Pharmaceutical Co., Ltd., and one of them is Guizhou Deliang baishite Pharmaceutical Co., Ltd., whose highest price for the product has reached 12.8 yuan (specification: 0.35g * 12 capsules) Accession AMGA huangmin capsule: at present, there are 483 manufacturers of the same variety, 415 manufacturers of the same specification, and Shanghai anding Biology (Tangyin) pharmaceutical industry is out of the market Accession Amkahuang min granules: at present, only Guangzhou Xiangxue Pharmaceutical Co., Ltd produces amkahuang min capsule, which can relieve the symptoms of fever, headache, aching limbs, sneezing, runny nose, stuffy nose and sore throat caused by common cold and influenza It is a common medicine for common cold According to the registration and acceptance database of smart drugs, Jinzhou Jiutai Pharmaceutical Co., Ltd obtained the production qualification of Ankahuangmin capsule, and Chengdu Tianyin Pharmaceutical Co., Ltd obtained the clinical approval of the product Six pharmaceutical enterprises, including Zhejiang Kangenbei Pharmaceutical Co., Ltd and Yabao Pharmaceutical Co., Ltd Taiyuan Pharmaceutical Co., Ltd., have applied for supplement of amkahuang min capsule, which has been approved Information source: data source of SDA: This article is the integrated content of the drug intelligence database, the view only represents the author, not the position of the drug intelligence network, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.