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Drug quality management specification

发布时间: 2013-08-01  分类:news  浏览次数: 3065

According to the State Food and Drug Administration's overall work plan, the newly revised GSP will soon officially promulgated. The revision work lasted longer, amendments to adjust the content more extensive comments. On the revision of the whole idea, both considered the continuity of monitoring the implementation of the current GSP, but also focus on the overall management level to promote the industry and technology advances, especially for the healthy and sustainable development of macro guidance on full consideration of deepening health reform policy requirements, comply with the industrial policy of the industry's development plan, closely linked to the policies and regulations on the industry rectifying and standardizing the objectives to ensure that the new version of the GSP scientific, advanced, practical and feasible. New GSP both in form and content and breakthroughs made major adjustments, reflecting the development of today's pharmaceutical distribution industry's latest management level, followed by the international drug distribution norms latest ideas, focusing on the development of national regulatory policy requirements, a larger degree of innovation.
1 controls the entire supply chain
   The revised draft to overcome the existing standardized management scope is limited to drug circulation problems, will cover a reasonable range of GSP to adapt to drug production, circulation and all involved in drug sales, storage and transportation activities, the implementation of drug quality from the production factory, transportation, distribution storage, distribution and sale and use of the terminal until the whole process of effective control, the elimination of existing norms exist in the production and circulation of convergence, convergence circulation and circulation, circulation and use of convergence, third-party logistics, warehousing and transportation links blind quality control to achieve a truly effective quality control of large circulation goals.
(2) learn from advanced international concepts
   The revised draft of the drafting process, fully learn from the relevant international advanced distribution management rules, including the WHO "Good circulation management norms Drug", "European Medicines good circulation norms" (EU Guideline on Good Distribution Practice of Medicinal Products for Human Use), Japan's GSP 2007 (Draft) (Japanese Good Supplying Practice), the United Kingdom "drug wholesale sales quality management practices" (Code of Good Pharmaceutical Wholesale Distribution Practice), Singapore's GDP and other, learn from, and references related to the content and concept of quality management system based on the quality of risk prevention, scope, and validation of pharmaceutical cold chain management, enterprise information management, automatic temperature and humidity monitoring, logistics, technology and application, transport, process management, high-risk species management, quality system audit, etc., combined with China's legal system characteristics and development of the industry a reasonable degree of absorption and adoption, as much as possible so that the new revised version of the current rules governing the flow of international advanced standards and to move closer.
3. The establishment of quality risk prevention mechanism
   The revised draft fully embodies the GSP preventive quality management philosophy, in circulation management purchase, sale, storage, transportation and other sectors to strengthen the quality of accident prevention to establish an effective management mechanism, a clear implementation of GSP's highest goal is to establish an effective quality management mechanism to prevent quality problems, eliminate quality accident, changing the focus only on the current GSP treatment quality, and solve quality problems retarded quality control mechanisms.
4 Total Quality Management and Total Quality Management
   New revised version reflects the company objectives of total quality management, emphasis on corporate staff positions full participation in quality management requirements. The implementation of quality management is the enterprise business objects and management of various aspects, requires that all aspects of strict accordance with the GSP rules to carry out the work, quality control to prevent loopholes and eliminate quality problems, which requires the management aspects of the quality of personnel should be clearly duties in strict process operation, the quality of responsibilities to each staff positions, clear quality management system management relations, to ensure the quality of supervision and management departments mandate effectively implemented.
5 Quality Management System
   The revised draft of a comprehensive quality management system, strengthen the management philosophy, requiring enterprises to implement the GSP process, organizational structure, management files, staffing, hardware construction, process execution, and risk prevention mechanism to create a system of quality management, quality of implementation management of scientific, rigorous, rational and effective.
6.GSP the effectiveness of the implementation of
   This revision changes the current version of the GSP to focus only on the corresponding conditions require, while ignoring the corresponding management objectives reflect the effectiveness of purpose, the management requirements are put forward a clear goal, to encourage enterprises to actively adopt effective, science, advanced methods to achieve the goals of quality control, so that the effectiveness of GSP really play. Put an end to the current enterprise implementation of GSP goals are not clear, the effect is not ideal, focusing on response check out the surface in the form of the phenomenon.
7 prominent drug quality and safety control
   Monitoring the quality of the new revised version of the concept in a useful breakthrough, the enterprise quality management objectives to rise to ensure that the people safe and effective medication, change the existing norms of quality control objectives confined to the narrow scope of the quality of drugs. Under this theory, the quality of corporate management responsibilities not only to ensure medicines management process itself, the quality reliability and stability, but also to assume the safety and reliability of the drugs, including the circulation process safety drug quality control, management of safety prevention, safe and controllable channels, the use of safe and effective.
8 Strengthening cold chain management
   Currently the field of quality control of medicines in circulation is a major outstanding problem is the pharmaceutical cold chain storage, transportation management, the current GSP medicines for cold chain quality control is also imperfect, imprecise defects. The revised draft on the management of the cold chain storage and transportation of drugs presents a comprehensive, scientific, rigorous and effective management regulations and requirements, system management, personnel qualifications, operational procedures, hardware facilities, monitoring tools and other aspects of a comprehensive and specific requirements , solve the cold chain drug quality control of the weak links and prominent issues, to achieve the whole process, the whole chain of cold chain quality management objectives, the elimination of possible cold chain scission phenomena, which greatly improve China Pharmaceutical Cold Chain management level in order to solve the vaccines, biological products such as cold-chain drug quality issues frequent phenomenon has laid a normative basis.
9 Storage temperature and humidity automatic monitoring
   The revised GSP requirements reflect the effectiveness of the implementation of the target. For quality control of pharmaceutical distribution process is the main part of storage and transportation, and storage and transportation process quality control of drugs is a major factor in temperature and humidity, therefore, for quality control of pharmaceutical distribution process is a key element of the monitoring and control of temperature and humidity. For a long time, China's pharmaceutical distribution process for the storage and transport links monitoring and control of temperature and humidity conditions, as monitoring tools, equipment, and lack of awareness, mainly artificial time observation records, there is a mere formality, untruthful, management control, etc. problem. To meet the state of the pharmaceutical distribution industry scale, intensive development requirements, as well as the effectiveness of drug quality control management objectives, the newly revised draft draws on international advanced management techniques and philosophy, pharmaceutical storage areas required to achieve full automatic monitoring of temperature and humidity , recording, tracking, alarm management, and quality control of pharmaceutical storage areas of the authenticity and validity of management mode and effect to achieve a major breakthrough.
10 new models to adapt to the development of the industry
   With the recent rapid development of the pharmaceutical distribution industry, the pharmaceutical distribution model also presents a variety of development and change, the emergence of e-commerce, third party logistics, specialized logistics, distribution network construction based drug form of circulation. To meet the development of the industry, this GSP revision appeared on our current circulation of new formats, new models conducted a special investigation and analysis, the corresponding terms and requirements for the new format has been taken into account to ensure that the new revised version can adapt main circulation types of models, but also to adapt to the current and possible future development has emerged multi-format pattern characterization requirements.
11 conform to IT development
   Current industry-wide IT development has presented a comprehensive application of the situation, relatively speaking, the pharmaceutical distribution industry IT applications is lagging behind, this revision on drug distribution management information technology applications, and quality management requirements for specific provisions, in particular combined with the national implementing drug electronic monitoring code management, enterprise information management system and quality management functions for specific requirements in order to achieve the quality control of drugs and drug quality retroactive effective automation technology.
12. Encourage the use of modern pharmaceutical logistics technology
   Modern pharmaceutical logistics as a representative of the advanced productive forces, has been in China's pharmaceutical distribution industry for the effective promotion, this revised version of the concept of modern logistics, management, technology, equipment configuration are required. Modern pharmaceutical logistics models put forward and forward, the next step will be to China's pharmaceutical distribution industry specialization, scale, third-party logistics development technical preparedness of the entire industry adapt to the depth of medical reform policies to promote the foundation.


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