Improve the quality of traditional Chinese medicine and improve the traceability system

[policies and regulations of chinapharma.com] on February 3, Beijing food and Drug Administration issued the notice on Further Strengthening the supervision of the production of Chinese herbal pieces, which requires Chinese Herbal Pieces enterprises to implement batch number management for Chinese herbal medicine, auxiliary materials and drug packaging materials, to track by batch number, and to severely crack down on the production and sales of Chinese herbal pieces without certificate and beyond the scope If there is any misuse, falsification, forgery of inspection results or data, or the use of inspection atlas in the inspection, or the inspection is not in accordance with the inspection procedures and specifications, it shall be dealt with seriously according to law If the circumstances are serious, it shall be regarded as a serious defect of GMP, and the GMP certificate shall be withdrawn (to improve the quality of traditional Chinese medicine from the source and improve the traceability system of drugs picture source: Baidu picture) the notice made it clear that within the scope of the site, facilities and equipment of the approved drug production license and GMP certificate, without approval, no behaviors unrelated to the research, production and sales of decoction pieces are allowed Strengthen the traceability management of Chinese herbal medicine, processing auxiliary materials and drug packaging materials The production enterprises of Chinese herbal pieces must organize production in strict accordance with the relevant requirements of GMP and the process procedures of varieties The whole process of processing must be completed in the approved plant Batch production records shall be timely, authentic and complete to record the processing process According to the analysis of the insiders, the new regulatory regulations issued by the drug regulatory system will indicate that in 2018, the regulation of relevant departments on traditional Chinese medicine and traditional Chinese medicine will be more fierce To improve the quality of traditional Chinese medicine from the source in this new regulation, it is emphasized that the production enterprises of traditional Chinese medicine pieces must organize production in strict accordance with the relevant requirements of GMP and the technological procedures of varieties, the whole process of processing must be completed in the approved plant, and the batch production records should be timely, authentic and complete to record the processing process Chinese herbal pieces can only be put on the market after passing the whole item inspection batch by batch Liquid chromatography, gas chromatography and other inspection equipment shall have the effective audit tracking function, and implement the authority management The results of microscopic, thin-layer chromatography and other inspection items shall be retained in the form of images In recent years, there have been many incidents of making and selling fake Chinese herbal medicines and pieces of Chinese herbal medicines, dyeing and doping, increasing weight, and operating beyond the scope, which have caused a relatively bad impact on the society Therefore, in 2016, the pharmaceutical supervision system launched special rectification actions for many times, and found that there are various problems in the market, such as secondary filling, dyeing and weighting, doping and illegal processing, which are very serious According to the statistics of GMP certificates withdrawn nationwide in 2016 released by the State Food and Drug Administration on February 8, a total of 170 GMP certificates of 162 pharmaceutical enterprises were withdrawn nationwide in 2016 Among them, 80 recovered GMP certificates are from Chinese herbal medicine enterprises, accounting for nearly 50% Industry insiders pointed out that strengthening management at the source is the fundamental solution to the quality of traditional Chinese medicine From the early stage of traditional Chinese medicine procurement channel, it was traded in rural market and drug distribution center, and now it has developed into the front-end procurement of authentic Chinese medicine in the market, and the future development direction is the base construction "A great deal of energy has been invested in the field of circulation and all work has been done afterwards We must pay attention to the strict control of the planting end, including provenance, environment, management and processing methods." It is emphasized in the notice to improve the traceability system of drugs to strengthen the traceability management of traditional Chinese medicine, processing auxiliary materials and drug packaging materials The manufacturer of Chinese herbal pieces shall strictly implement the supplier audit, and its purchase, stock in and stock out account, bills, etc shall be timely, authentic and complete Batch number management shall be carried out for Chinese herbal medicine, auxiliary materials and drug packaging materials within the enterprise of Chinese herbal medicine, so as to realize tracking by batch number With the development of national economy and the further improvement of people's health needs, the demand for Chinese herbal medicines is growing larger and larger Some valuable herbal medicines or those with a long growth cycle often have periodic price inflation and plummet, which leads to the phenomenon of making fake and selling fake, dyeing and even selling the extracted dregs as raw herbal medicines (pieces of decoction) It is an urgent task to improve the modernization level of the circulation of traditional Chinese medicine so as to ensure the quality of the circulation of traditional Chinese medicine and the health and safety of the people As early as October 2012, the Ministry of Commerce issued the notice of the general office of the Ministry of Commerce on the pilot construction of the circulation and traceability system of traditional Chinese medicine, which decided to apply modern information technology and Internet of things technology in the pilot cities, through the electronic labels on the packaging of traditional Chinese medicine products, to carry out electronic registration of the information related to the origin, production and processing, market circulation, pharmacy use and other links of traditional Chinese medicine To carry out the pilot construction of the circulation and traceability system of traditional Chinese medicine The person in charge of the market order Department of the Ministry of Commerce said that with the establishment of the traceability system for the circulation of traditional Chinese medicine, the modernization level of the circulation of traditional Chinese medicine will be raised to a new level, the quality and safety of traditional Chinese medicine will be more guaranteed, and the people will be more relieved to use medicine Notice of Beijing food and Drug Administration on Further Strengthening the supervision of the production of Chinese Herbal Pieces In order to further strengthen the supervision of the production of Chinese herbal pieces and ensure the quality and safety of drugs, in accordance with the drug administration law of the people's Republic of China, the regulations for the implementation of the drug administration law of the people's Republic of China and other laws and regulations, as well as the Pharmacopoeia of the people's Republic of China, the specification for the quality management of drug production and its appendix (hereinafter referred to as the GMP), Beijing Herbal Pieces According to the technical requirements such as "processing specification", combined with the situation of Chinese Herbal Pieces in China and the actual situation of our city, the following requirements are put forward for the production supervision of Chinese Herbal Pieces in our city, please comply with them 1 The varieties produced and sold by the manufacturers of Chinese Herbal Pieces in our city shall be consistent with the scope specified in the drug production license and GMP certificate within the validity period 2 The production enterprises of Chinese herbal pieces shall not engage in other production and operation activities as producers of Chinese herbal pieces, and shall not engage in activities unrelated to the research, production and sales of Chinese herbal pieces without approval within the scope of the site, facilities and equipment of the approved drug production license and GMP certificate 3 Severely crack down on the production and sale of Chinese herbal pieces without certificate and beyond the scope Including selling drugs to units or individuals without legal qualification; forging the source of drug purchase and the flow direction of drug sales; when purchasing and selling drugs, the licenses (licenses), tickets (invoices, bills accompanying the goods), accounts (physical accounts, financial accounts), goods (physical drugs) and payments (payments) cannot correspond to each other, etc., the records of drug purchase and sale are incomplete and untrue, and the production and operation behaviors cannot be traced Tracing: production, storage and sales of Chinese herbal pieces outside the approved production site (including storage and inspection) (except for the toxic Chinese herbal pieces that have been adjusted and filed) 4 Strengthen the traceability management of traditional Chinese medicine, processing auxiliary materials and drug packaging materials The manufacturer of Chinese herbal pieces shall strictly implement the supplier audit, and its purchase, stock in and stock out account, bills, etc shall be timely, authentic and complete 5 Batch number management shall be carried out for Chinese herbal medicine, auxiliary materials and drug packaging materials within the enterprise of Chinese herbal pieces, so as to realize tracking by batch number 6 The production enterprise of Chinese herbal pieces must organize production in strict accordance with the relevant requirements of GMP and the technological procedures of the varieties The whole process of processing must be completed in the approved workshop The batch production record shall be timely, authentic and complete to record the processing process 7 Chinese herbal pieces can only be put on the market after passing the batch by batch inspection Liquid chromatography, gas chromatography and other inspection equipment should have the effective audit tracking function, and implement authority management The results of microscopic, thin-layer chromatography and other inspection items should be retained in the form of images 8 the enterprises producing Chinese herbal pieces shall pay attention to the changes of laws and regulations and standards and update them in time The supplementary inspection methods issued by the State Food and drug administration are mandatory items Meanwhile, risk assessment shall be carried out for the products before release to encourage the enterprises to independently increase the illegal methods for inspection Nine After risk assessment, data accumulation and verification (in principle, no less than 30 batches of finished products, excluding toxic decoction pieces), the test data can be transferred based on the test results of Chinese herbal medicine, intermediate products, finished products and other parts, but the types and items of data transfer must be clearly defined in the form of documents, and no less than 3 batches of decoction pieces and corresponding batches of herbal medicine transfer data items should be carried out for each variety every year To review 10 in case of applying, tampering with, falsifying inspection results or data, using inspection atlas falsely or failing to inspect according to inspection procedures and specifications in the inspection, it shall be dealt with seriously according to law If the circumstances are serious, it shall be regarded as a serious defect of GMP, and the GMP certificate shall be withdrawn 11 the scale and equipment of the quality inspection laboratory of the Chinese herbal medicine production enterprise shall be suitable for the variety of production, and the individual items that need to be entrusted for inspection shall be put on record The entrusting party must ask for the results of the entrusted inspection items according to the batch, keep the inspection records, Atlas and other relevant materials, and be responsible for the authenticity and integrity of the data of the entrusted inspection items All District bureaus and sub bureaus directly under the central government should include the production enterprises of Chinese herbal pieces into the scope of key supervision, and take flight inspection and surprise inspection as the routine means of supervision In accordance with the law and regulations, strictly investigate and deal with the illegal acts of the Chinese herbal medicine production enterprises, and transfer them to the public security organs for criminal responsibility in time if they are suspected of crimes The Municipal Bureau will also organize the flight inspection of enterprises producing Chinese herbal pieces, and supervise the work of the District Bureau and the sub Bureau directly under it Beijing food and Drug Administration January 24, 2017