Concentrated examination of traditional Chinese medicine extracts from Jiangxi tissue

Recently, Jiangxi food and Drug Administration organized the inspection team to carry out on-site inspection of traditional Chinese medicine extracts in Anhui, Shaanxi and Guangdong respectively, in order to strengthen the supervision and management of traditional Chinese medicine extracts and extracts, standardize the production behavior of traditional Chinese medicine, and ensure the quality of traditional Chinese medicine in the Province In recent years, with the large-scale and intensive development of traditional Chinese medicine production, the problems in the extraction or outsourcing of traditional Chinese medicine extracts are more prominent, which brings hidden dangers to the quality and safety of traditional Chinese medicine Jiangxi Provincial Bureau carefully combed the use of extracts for filing in the province's proprietary Chinese medicine production enterprises, and selected three extraction production enterprises and four extraction varieties (menthol, menthol oil, liquorice extract, liquorice flow extract) that are more used by the province's proprietary Chinese medicine preparation enterprises for extended inspection to confirm whether the extraction production enterprises meet the GMP requirements and the registered health Production process, and check the use and filing of extracts of some Chinese patent medicine preparation enterprises in this province The Provincial Bureau has formulated the overall inspection plan of the whole province, made detailed preparations in terms of inspection requirements, fund guarantee, etc., centralized the mobilization of the backbone strength of GMP inspectors to participate in the inspection, and assigned special personnel to each group to be responsible for coordination, guidance and supervision, so that the inspection work can be carried out smoothly as scheduled All inspection teams carefully check the purchase channels of Chinese herbal medicine and Chinese herbal pieces, relevant qualification certificates, supplier audit, quality inspection, production process, material balance, sales flow, etc In the on-site inspection, 24 problems of extract production enterprises were found, and the inspection team fed them back to the enterprises and local drug regulatory authorities in time, requiring the enterprises to rectify as soon as possible to ensure compliance At the same time, according to the extended inspection, Jiangxi Provincial Bureau checked the enterprises in the province, found 15 problems, and transferred these problems to the local municipal bureau, and ordered the Municipal Bureau to seriously investigate and deal with the serious cases in accordance with the relevant laws and regulations Next, Jiangxi Provincial Bureau will also organize drug regulatory departments at all levels to conduct extended inspection on other extract production and use enterprises, so as to achieve full coverage for three years and further improve the quality and safety level of traditional Chinese medicine preparations in the province.