Grasp the focus of continuous efforts Quanzhou to strengthen the supervision of Chinese herbal medicine tablets

Recently, quanzhou City, Fujian Province, the Food and Drug Administration issued "on the implementation of the 2018 Chinese herbal medicine drink tablets special rectification notice" (hereinafter referred to as "Notice"), decided to deploy in the city-wide implementation of a four-month special treatment of Chinese herbal medicine tablets.
understood that since 2015, Quanzhou Food and Drug Administration has been in the city for four consecutive years to organize the supervision and inspection of Chinese herbal medicine tablets and supervision of special actions. "In the specific rectification work, we have always adhered to the 'defensive and consistent, focus on the rule of law' principle, through continuous efforts, and gradually from the source to establish control, traceability, investigation mechanism. At present, the quality and safety management level of Chinese herbal medicine tablets in the jurisdiction has been further improved, and the production and operation order has been continuously standardized. Cai Tianshua, director of the Quanzhou Food and Drug Administration, said.Key Varieties Key Rectification
Since 2015, Quanzhou Food and Drug Administration has determined the key varieties in advance and appropriately reduced them according to the actual and historical special rectification work of the Bailiwick, while focusing its efforts on the outstanding problems existing in the production, circulation and use of Chinese herbal medicine tablets in the Bailiwick, and digging deep into regional, systematic and universal risks.
, for example, in 2015, we identified 23 key varieties, and this year, we closely combined with the 2018 Chinese herbal medicine tablets special treatment 'wind action' sampling of 38 varieties, 2017 Chinese medicine The 10 varieties with high failure rate of special rectification and sampling of Chinese medicine tablets, as well as 5 varieties with high social concern, increased the number of key varieties to 46, including serum, Ume, barren, sourdough, zea, grain and so on. Chen Zhaoxu, head of the drug supervision section of Quanzhou Food and Drug Administration, introduced.
At the same time, after the end of the annual centralized rectification work, Quanzhou Municipal Food and Drug Administration will also timely organize the city and county level food and drug regulatory department staff and the jurisdiction of Chinese medicine tablets production and operation enterprise quality management personnel, the year's centralized rectification work found in the quality and safety issues and the risk information collected from the national quality bulletin to carry out risk research, and further enhance the quality and safety management level of Chinese medicine tablets.
In order to continuously standardize the order of production and operation of Chinese herbal medicine tablets in the jurisdiction, Quanzhou City also requires enterprises to further improve the acceptance standards for further goods, through the investigation of risks, fill loopholes, promote rectification, to avoid the problem of Chinese herbal medicine tablets into the market. In addition, since 2017, Quanzhou City has also introduced an interview admonition mechanism, the previous year's special rectification of the emergence of non-conforming units for collective interviews. Over the past two years, 23 units with product quality problems have been interviewed and asked to further implement the corporate responsibility.Seven training to enhance capacity
" after the identification of key varieties, we will organize drug testing institutions in the senior Chinese medicine testing technical personnel, for key varieties and common pseudo-shoddy herbs, prepared into a graphic and lush Chinese herbal medicine identification atlas and other training materials, and in Quanzhou City Food and Drug Administration portal for public release, for Chinese medicine practitioners to carry out daily control. At the same time, the city held a training course on the identification of Chinese herbal medicine tablets, targeted to strengthen the food and drug regulatory department staff and Chinese herbal medicine tablets production and operation enterprises related personnel training, to enhance law enforcement officials and Chinese medicine practitioners of Chinese medicine tablets identification capacity. Chen Zhaoxu said.
After the annual training of Chinese herbal medicine tablets, Quanzhou City will immediately organize the production and operation enterprises of Chinese herbal medicine tablets in the jurisdiction to carry out a month-long self-examination and self-correction work. According to the Notice, the 2018 self-examination and self-correction work is scheduled for June.
Wu Jian, general manager of Fujian Mingyuan Pharmaceutical Co., Ltd., said: "The company this year has 10 items to self-check and self-correction projects, including whether to hold relevant certificates, Chinese herbal medicine procurement and acceptance personnel have been trained, whether they have the ability to identify the authenticity of Chinese medicine.
Zeng Yanling, general manager of Quan'an Pharmaceutical Chain Co., Ltd., Fujian Province, said that the company this year has nine self-checking items, including whether the purchase of Chinese medicine tablets with-on-shipment invoices, lists and stamped supplier seal certificate, whether there is a violation of the provisions to engage in Chinese medicine tablets packaging, change labels and so on. For some key varieties of self-examination and self-correction, we will refer to Quanzhou City Food and Drug Administration portal published on the identification album. Zeng Yanling said.
At the same time that enterprises conduct self-examination and self-correction, Quanzhou Municipal Food and Drug Administration will also urge pharmaceutical production and operation enterprises in the jurisdiction to pay close attention to the quality announcement of the State Drug Administration, Fujian Food and Drug Administration, the announcement of the higher frequency of non-conforming production enterprises and easy to occur dyeing, weight gain, doping and adulteration varieties to focus on self-examination, and strengthen the supplier audit, verify the legitimate identity of the supplier sales staff, if necessary, to carry out quality inspection of non-conforming suppliers.Completely investigate and punish the purification market
According to the Notice, from July to August 2018, Quanzhou city food and drug regulatory departments at all levels will carry out comprehensive special inspection and supervision of the outstanding problems and weak links in the field of the production and circulation of Chinese medicine tablets in the jurisdiction. "Notice" requires that the production of Chinese medicine tablets, wholesale, chain headquarters enterprises, as well as township and above medical units to reach 100% on-site inspection coverage, Chinese medicine tablets retail enterprises, clinics should not be less than 50 inspections.
, we will take a combination of supervision and inspection and supervision sampling, and carry out targeted supervision and inspection on the production and operation of Chinese herbal medicine tablets. Among them, the production link, will focus on the inspection of Chinese herbal medicine purchase channels, prescription technology, material balance, quality inspection, batch production records, sales records and other conditions, serious investigation and punishment of enterprises directly purchased Chinese medicine drink tablets finished products for sub-packaging, change packaging labels and "tickets, hanging" way to operate non-enterprise production of Chinese medicine tablets and other violations, and severely crack down on enterprises and individuals without legal qualifications engaged in the production of Chinese medicine tablets illegal acts. For the circulation of the use of links, the purchase channel as a breakthrough, spot checks of nearly 6 months of sales tax tickets, accompanying peer lists, inspection reports and other valid evidence to trace back to the source, the management of Chinese medicine and beverage tablets business units did not obtain legal bills, not attached to the certificate and inspection report and other irregularities.
" for the general problems found in the supervision and inspection, we will use closed-loop management, carry out follow-up inspection, urge the relevant units to rectify in place. For some outstanding problems, the technical support role of pharmaceutical personnel will be given full play, and targeted supervision and testing will be carried out. Cai Tianshua said, "At the same time, we will highlight the investigation of a number of typical cases in the special rectification." (China Medical Journal)