Drug management quality management regulations released

Recently, the newly revised "Public Drug Quality Management Standard" (hereinafter referred to as Drug GSP) was officially released and will be formally implemented on June 1, 2013. Drug GSP is the basic guideline for pharmaceutical business management and quality control. After the current pharmaceutical GSP was promulgated and implemented in 2000, after 10 years of practice, it has played a very important role in improving the quality of pharmaceutical companies, regulating the behavior of pharmaceuticals, and ensuring the quality and safety of pharmaceuticals. However, with the rapid economic and social development of our country, the current drug GSP has not been adapted to the development of drug circulation and the requirements for drug regulatory work. Since 2005, the State Food and Drug Administration has started investigation and research, explored the concept of scientific supervision in the revision of pharmaceutical GSPs, effectively improved the effectiveness of regulatory work, and officially started the revision work in 2009. In the process of revision, the State Food and Drug Administration has extensively drawn lessons from the World Health Organization and the pharmaceutical circulation regulatory policies of the United States, the European Union and other developed countries and regions, comprehensively investigated the status of the pharmaceutical circulation industry in China, and widely solicited opinions from all parties, and finally formed a pharmaceutical GSP. The revised draft was reviewed and approved by the Ministry of Health's departmental meeting and officially released.

This revision clarifies the goal of “fully advancing one management tool, strengthening two key links, and breaking three difficult issues”. One management tool is to implement the enterprise computer management information system. Two key links are the purchase and sale of medicines and storage temperature and humidity control. The three difficulties are bill management, cold chain management, and drug transportation.

The revised GSP has a total of 4 chapters, including general rules, quality management of drug wholesale, quality management of drug retail, and supplementary regulations, totaling 187 articles. The newly revised Drug GSP incorporates the current drug GSP and its implementation details and adds many new management elements. Such as the absorption of the concept of supply chain management; increased computer information management, storage temperature and humidity monitoring, drug cold chain management and other management requirements; the introduction of the quality of risk management, system internal audit, equipment verification and other new management ideas and methods. The newly revised pharmaceutical GSP is based on the requirements for improving the quality management system, and includes all aspects of quality management elements such as personnel, institutions, facilities and equipment, and system documentation of pharmaceutical companies, as well as procurement, acceptance, storage, maintenance, sales, transportation, and after-sales management. New regulations have been made.

The newly revised Drug GSP has comprehensively improved the hardware and software standards and requirements of the company's operations. While guaranteeing the quality of drugs, it has also increased the market access threshold, helped to inhibit low-level duplication of businesses, promoted industrial restructuring, and increased market concentration. In terms of software, the newly revised GSP clearly requires companies to establish quality management systems, establish quality management departments or staff with quality management, and put forward detailed requirements for a series of quality management system documents such as quality management systems, job responsibilities, operating procedures, records, and certificates. , And emphasized the implementation and effectiveness of the document; improved the company responsible person, the person in charge of quality, the person in charge of the quality management department and the qualification requirements of personnel in the quality control, acceptance, maintenance and other positions. On the hardware side, the newly revised drug GSP fully implements computerized information management, and emphatically stipulates the functional requirements of computer management facilities, network environment, databases, and application software; it stipulates that enterprises should adopt automatic temperature and humidity monitoring systems for drug warehouses and implement continuous implementation of the storage environment. , Effective real-time monitoring; Requires the provision of specific facilities and equipment for the storage, transportation of frozen and frozen drugs.

In response to the weak links in drug regulation, the newly revised Drug GSP has added a series of new systems. Concerning the problem of unregulated drug operation, unclear purchase and marketing channels, and confusion in the management of bills, the newly revised drug GSP clearly requires that the purchase and sale of drugs must be issued an invoice, and that the outbound drug must be shipped (with a single ticket) and checked at the receiving stage. , Logistics activities should be consistent with the ticket, account, and goods in order to achieve the goal of standardizing drug operations and maintaining the order of the pharmaceutical market. For commissioned third-party transportation, the newly revised pharmaceutical GSP requires the client to inspect the carrier's transportation capacity and related quality assurance conditions, enter into an entrustment agreement with a clear quality responsibility, and request quality tracking of the transportation process through records to strengthen corporate quality responsibility. Awareness and improved risk control capabilities. For cold chain management, the newly revised Drug GSP has increased the requirements for storage and transportation facilities for refrigerated and frozen pharmaceuticals, and in particular stipulated the handover procedures and temperature monitoring, tracking, and inspection requirements for such drugs in the transportation and receiving sectors. Strengthen the quality assurance ability of high-risk varieties.

The newly revised pharmaceutical GSP is closely linked with new policies such as the 12th Five-Year Plan for medical reform and the 12th Five-Year Plan for pharmaceutical safety. In order to implement the “12th Five-Year Plan of Medical Reform” and the “Twelfth Five-Year Plan” for drug safety on the requirements for electronic supervision and ensuring the traceability of drugs during the whole process of the full range of drugs, the newly revised Drug GSP stipulates that drug trading companies should formulate and implement electronic supervision of drugs. The system puts forward specific requirements for the operations such as barcode scanning and data uploading for drug inspection, revenue collection, delivery, and sales. In order to meet the requirements of the 12th Five-Year Plan for Drug Safety in the provision of licensed pharmacists, the newly revised Drug GSP specifies that the legal representative or person in charge of a pharmaceutical retail company should have the qualification to practise pharmacists; enterprises should be equipped with licensed pharmacists in accordance with the relevant regulations of the State. Responsible for prescription review and guide rational drug use.

The State Food and Drug Administration has set a three-year transition period for the new revision of the drug GSP implementation. After the stipulated period of 2016, enterprises that still cannot meet the newly revised GSP requirements for pharmaceuticals will stop their pharmaceutical business activities in accordance with the relevant provisions of the Drug Administration Law. The State Food and Drug Administration will promptly issue specific implementation procedures, strictly supervise the implementation of the newly revised Drug GSP, further strengthen the management of pharmaceutical business quality, standardize the behavior of pharmaceutical operations, and earnestly ensure that the public use drugs are safe and effective.