Here comes the guidance of Anhui drug traceability!

Food and Drug Administration of cities and counties directly under administration: according to the notice of the people's Government of Anhui Province on key work and responsibility decomposition in 2018 (WZ [2018] No 23), this year our bureau issued guidance on the construction of drug production quality traceability system (for Trial Implementation) to pilot in some local enterprises, and achieved good results Now, the guiding opinions on the construction of drug production quality traceability system (for Trial Implementation) is printed and distributed to you Please carefully organize the implementation Annex: Guidance on the construction of drug production quality traceability system (Trial Implementation) Anhui food and Drug Administration October 15, 2018 (publicity attribute: active publicity) Annex: Guidance on the construction of drug production quality traceability system (Trial Implementation) According to the general office of the State Council's opinions on accelerating the construction of traceability system for important products (GBF [2015] No 95), the former State Food and Drug Administration's opinions on promoting the improvement of traceability system for food and drug producers and operators (sfyjk [2016] No 122) and the notice of Anhui Provincial People's Government on key work and responsibility breakdown in 2018 》(WZ [2018] No 23) requires that the guidance is specially formulated to control drug safety risks, better implement the drug production quality management specification, and guide drug manufacturers to accelerate the construction of drug production quality traceability system in our province 1、 The construction goal is to realize the traceability of information data in the whole process of internal production quality of pharmaceutical enterprises, and the traceability of sales flow in the external market In case of quality and safety problems, timely recall relevant products and trace the causes of quality and safety 2、 Construction content (I) internal production quality traceability the drug manufacturer shall record all activities in accordance with the requirements of GMP, and the records shall be true, accurate and complete, so as to realize the traceability of "human, machine, material, law, environment and test" information of each batch of products 1 The information of manufacturing personnel can be traced According to the product batch number information, it can be traced back to each production process post operator, quality assurance personnel (QA), samplers, release reviewers, approvers, positions and other information 2 Production equipment and facilities information can be traced According to the product batch number information, it can be traced back to the name, model, code and status of the equipment used in each production process and process step, as well as water system, air conditioning system, refrigeration system, compressed air and other facilities and equipment 3 Traceability of production material information According to the product batch number information, it can be traced back to the batch number, quantity, manufacturer, supplier name, inspection status and other information of each raw and auxiliary material used by the product 4 The process parameter information of production prescription can be traced According to the product batch number information, it can be traced back to the product production order, the collection point of key process parameter data (including the process and quality monitoring information of key operation process), the product quality attribute information, the name, number, version of such documents as the process procedure and operation procedure used in production, as well as various deviations in the production process 5 Production and manufacturing environment information can be traced According to the product batch number information, it can be traced back to the room number, site clearing, disinfection, cleanliness level of each production process of the product, as well as the temperature and humidity conditions during production, environmental monitoring and other information 6 The production process quality inspection and product inspection information can be traced According to the product batch number information, it can be traced back to the information of the whole process of product inspection, including raw and auxiliary materials, intermediate products, product inspection, inspection data, Atlas, result report, inspection time, inspectors, reviewers, approvers, as well as all kinds of OOS in the inspection process （2） To track the sales flow in the external market, pharmaceutical manufacturers should take appropriate measures to track the flow of products sold in the market and grasp the market flow of products sold in the market in a real-time and dynamic way Drug manufacturing enterprises are encouraged to assign unique marks to the minimum sales units of products and provide verification services for drug production information so as to facilitate the identification of operators and consumers Injection, blood products and other high-risk pharmaceutical manufacturers should give priority to the use of information technology to trace the products on the market 3、 Construction requires (1) high attention and steady implementation Pharmaceutical production quality traceability system is an important part of the quality and safety management system of pharmaceutical production enterprises Pharmaceutical production enterprises should attach great importance to it, actively assume the main responsibility of the construction of pharmaceutical production quality traceability system, establish a special department or designate a special person to take charge of the work, and realize the traceability of production quality information of products in production by the end of December 2018 as required （2） It is convenient for enterprises to benefit the people Drug manufacturers are allowed to take a variety of ways to realize product quality information traceability in combination with their own actual and management needs It is encouraged to adopt modern information technology to carry out the construction of quality traceability system For enterprises that do not yet have electronic product quality traceability system, effective management measures shall be taken to effectively associate the "human, machine, material, law, environment and test" information of each batch of products, so as to ensure that all information archives related to the quality of each batch of products are not lost, damaged, stored in order, and easy to retrieve And find （3） Traceability, convenient and efficient The enterprise establishes the quality traceability management department, carries out the construction of the drug production quality traceability system, builds a complete enterprise product quality file, realizes the traceability of the whole process information data of the internal production quality of the product enterprise, and the traceability of the sales flow of the external market, so as to provide fast, efficient and accurate traceability platform support for consumers' quality query or quality abnormal improvement.