现阶段我国GMP制度有效实施的关键因素研究及其制度设计.doc

摘 要 Abstract Research of Significant Factor of GMP to Effcetive move and Its Design of System in Current Stage GMP system in China has made progress on improving Chinas pharmaceutical corporation management level, to improve drug quality and ensure safety and efficacy of the people. However, the implementation and development of GMP is a long-term task, during its development process still have some problems. This study aims to summarize experience and analysis the problem, and propose the recommendations, to get the reference for next phase of the GMP implementation and development. Through review and research the history of GMP production, development and improvement of USA and Japan, based on case studies, comparative demonstration of the GMP development and practice of China made a comprehensive and systematic analysis of exposition to dialectical seen in perspective GMP implementation in China has been achieved, summarized the problems, deeply analysis the source of the problem, learn from the practical experience of developed countries, puts forward the new era of China drug GMP implementation and development of recommendations. In this paper, through method of theory and literature study and action research, by collecting relevant information, review domestic and international GMP development history, analysis of the current status of GMP system management, summarized Chinas pharmaceutical corporation existing problems, base on competence theory, learn from the experiences of advanced countries, the foundation of a collection of the authors own work practices, GMP system put forward to improve new ideas and new methods. In my opinion, the main factors affecting the implementation of GMP is the pharmaceutical corporations internal staff issues; the Construction of government departments lack of GMP inspectors, GMP system of relevant laws and regulations and technical standards for system imperfections and other reasons. This article applied competence theo