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According to the work plan for the special inspection of traditional Chinese medicine extracts in Gansu Province, the provincial food and Drug Administration organized the special inspection of traditional Chinese medicine extracts in Gansu Province from September to October This special inspection is combined with flight inspection to carry out inspection on Chinese herbal extract manufacturers, Chinese herbal medicine manufacturers, and pharmaceutical manufacturers that share and set up extraction workshops in different places within the group The plan is clear This inspection covers four categories of products with complex extraction process, high requirements, large production and use, wide sales scope, high-risk preparations such as traditional Chinese medicine injection, large price increase of traditional Chinese medicine and high product cost The enterprise involved in the production of traditional Chinese medicine injection, with approval number of Chinese patent medicine, but without extraction workshop or insufficient extraction capacity; sharing pre-treatment and extraction workshop; in recent years, the enterprise with a large number of unqualified varieties from national and provincial extraction
In addition, this inspection focuses on whether to produce or purchase traditional Chinese medicine extracts without filing; whether to audit the suppliers of the purchased raw materials for self extraction; whether to conduct quality assessment and supplier audit for the manufacturers of the purchased traditional Chinese medicine extracts for outsourcing; whether the purchase and production quantity correspond to the financial account; whether to produce in strict accordance with the approved process and prescription Whether the internal quality control standard is established and whether the production process is controllable; whether the inspection can be carried out in accordance with the legal standards; whether the extraction capacity matches the production variety and scale, and whether the material is balanced in the production process; whether the fake and inferior Chinese herbal pieces are purchased for extraction, and whether the illegal extraction is used; whether there is the entrusted processing of Chinese herbal extraction; whether it is not a record Management of traditional Chinese medicine extract, whether the quality management system is sound Four illegal advertising drugs were stopped In order to strengthen the supervision and management of drug advertising, crack down on illegal drug advertising, maintain the order of drug advertising in our province, and ensure the safety of public drug use, recently, the provincial food and Drug Administration decided to suspend the sale of four drugs, namely "Mingmu 25th flavor pill", "shenclam Pingchuan capsule", "xiantianma capsule" and "Guilong ointment", which are seriously illegal and misleading to consumers The provincial food and drug administration requires that all municipal and prefectural bureaus immediately notify drug distributors and users within their jurisdiction to suspend the sale of the above-mentioned illegal advertising drugs, and conduct supervision and sampling inspection when necessary; During the period of suspension of the sales of the above-mentioned illegal advertising drugs, the supervision and inspection of the pharmaceutical trading enterprises and users under their jurisdiction shall be strengthened If it is found that the above-mentioned illegal advertising drugs continue to be sold, it shall be investigated and punished according to law.