Five measures taken by Linyi food and drug administration to strengthen the special rectification work of traditional Chinese medicine production

In order to further standardize the production of traditional Chinese medicine in Linyi City, the food and Drug Administration of Linyi City recently issued the work plan for the special treatment of the production links of traditional Chinese medicine in Linyi city From now on to the end of June, five measures were taken to comprehensively investigate the quality risks and potential safety hazards in the production links of traditional Chinese medicine in Linyi City, so as to improve the quality and safety assurance level of traditional Chinese medicine in Linyi city First, strictly implement GMP and GPP system Focus on the inspection of Chinese herbal medicine and Chinese herbal extract production enterprises, Chinese herbal medicine preparation production enterprises (including preparation rooms of medical institutions), audit of Chinese herbal medicine suppliers, inspection of raw herbal medicine, whether the enterprise strictly complies with the requirements of the "drug production quality management specifications" and "preparation quality management specifications of medical institutions" The second is to implement the capacity scale registration system of traditional Chinese medicine production enterprises At the same time of supervision and inspection, the county and district bureaus are required to register the production conditions of the enterprises in charge of the production of Chinese herbal pieces According to the plant, equipment and facilities conditions of the enterprises and the varieties of production of the enterprises, the production capacity of each processing range and the annual maximum production capacity of Chinese herbal pieces are counted and evaluated The third is to implement the reporting system of the production of Chinese herbal pieces It is required that the production enterprises of Chinese Herbal Pieces fill in and report the production varieties, batch numbers, batches, Executive Standards and quality inspection of Chinese herbal pieces every half a year, so that the regulatory authorities can dynamically grasp the daily production of Chinese Herbal Pieces enterprises in their jurisdiction Four is to implement the examination system of new varieties of Chinese Herbal Pieces production enterprises Any new production varieties of Chinese herbal medicine production enterprises shall be equipped with inspection equipment and capacity suitable for the new production varieties, and can only be produced after examination It is required that the production enterprises of Chinese herbal pieces are strictly prohibited to produce beyond the approved varieties and scope Except for the special inspection items such as heavy metal and harmful elements, pesticide residues and aflatoxin of Chinese herbal medicines, the entrusted inspection is not allowed in principle Fifth, we will crack down on illegal production We will strictly investigate and deal with the illegal activities of processing and producing Chinese Herbal Pieces in disguised form, such as the illegal production of Chinese Herbal Pieces beyond the scope of license, and the purchase of Chinese herbal pieces by enterprises that produce Chinese herbal pieces and sell them in separate packages; and we will severely crack down on the illegal processing and production of Chinese Herbal Pieces in disguised form, such as the illegal cutting and indiscriminate system.