我国中小型制药企业GMP实施的探究

发布时间：2018-04-02 13:21

本文选题：药品GMP　切入点：有效实施　出处：《山东中医药大学》2013年硕士论文

【摘要】：药品是保证人民生命健康的特殊产品，药品质量管理具有特殊的重要性。药品GMP通过对药品生产全过程进行规范管理，确保制药企业遵循科学、系统的行业准则和行为规范，保证药品质量，维护人民群众用药的安全有效。药品GMP于上世纪80年代初引入我国，与美国制药行业相比晚了二十多年。我国药品GMP经历了四个发展阶段，即准备阶段、萌芽阶段、起步阶段、发展完善阶段。经过三十年的发展演变，我国药品GMP取得的进步是有目共睹的。通过实施GMP，药品质量得到了一定程度的保障，制药企业的综合素质得到了很大的提升。但是，还应当看到，我国GMP的贯彻实施还存在许多问题，这些问题不解决，将严重阻碍我国制药工业的发展。经过长期的努力和发展，我国药品GMP在文本上已经同发达国家的GMP相差无几，但在实施层面上，我国GMP同发达国家GMP还存在着较大的差距，特别是中小型制药企业的GMP实施问题更为突出。我国制药企业当中，中小型制药企业占据很大的比重，中小型制药企业GMP的实施状况在很大程度上决定着我国的药品质量，决定着人民群众用药的安全程度。中小型制药企业GMP实施中存在的问题，成为影响药品质量的关键和监督管理的难点。与此同时，中小制药企业GMP实施问题，也关系到中小型制药企业的长期稳定发展。所以，探索适合我国国情的中小型制药企业药品GMP实施模式，对于提升中小企业GMP实施水平，保证人民群众用药的安全有效，，促进我国制药企业健康发展，具有重要的理论意义和现实意义。本文从管理的角度，对药品GMP管理的4M要素和国外中小型制药企业药品GMP管理的先进经验进行研究,弄清我国中小型制药企业GMP实施的现状，探讨我国中小型制药企业GMP实施中存在的问题，并在此基础上,提出改进我国中小型制药企业GMP实施的政策建议，为提升我国药品GMP实施水平提供参考，为我国现存中小型制药企业克服危机迎接挑战提供发展思路。
[Abstract]:Medicine is a special product to ensure people's life and health, and drug quality management is of special importance.By regulating the whole process of drug production, GMP ensures that pharmaceutical enterprises follow the scientific and systematic industry standards and behavior norms, ensure the quality of drugs, and maintain the safety and effectiveness of drug use by the people.Drug GMP was introduced into China in the early 1980's, which was more than 20 years late compared with American pharmaceutical industry.Drug GMP in China has undergone four stages of development, namely, preparation stage, budding stage, initial stage and development stage.After 30 years of development and evolution, the progress of drug GMP in China is obvious to all.Through the implementation of GMPs, the quality of drugs has been guaranteed to a certain extent, and the comprehensive quality of pharmaceutical enterprises has been greatly improved.However, it should be noted that there are still many problems in the implementation of GMP in China, which will seriously hinder the development of pharmaceutical industry in China.After a long period of effort and development, the text of Chinese drug GMP is no different from that of developed countries' GMP, but on the implementation level, there is still a big gap between our country's GMP and developed country's GMP.In particular, the implementation of GMP in small and medium pharmaceutical enterprises is more prominent.Among the pharmaceutical enterprises in China, the small and medium-sized pharmaceutical enterprises account for a large proportion, the implementation of small and medium-sized pharmaceutical enterprises to a large extent determines the quality of drugs in China, determines the safety of drug use by the people.The problems existing in the implementation of GMP in small and medium-sized pharmaceutical enterprises have become the key to the quality of drugs and the difficulties of supervision and management.At the same time, the implementation of small and medium-sized pharmaceutical enterprises GMP, but also related to the long-term and stable development of small and medium-sized pharmaceutical enterprises.Therefore, to explore the implementation mode of drug GMP for small and medium-sized pharmaceutical enterprises, which is suitable for our country's national conditions, will promote the level of GMP implementation in small and medium-sized enterprises, ensure the safety and effectiveness of drug use by the people, and promote the healthy development of pharmaceutical enterprises in our country.It has important theoretical and practical significance.From the point of view of management, this paper studies the 4M elements of drug GMP management and the advanced experience of drug GMP management in foreign small and medium-sized pharmaceutical enterprises, and makes clear the current situation of GMP implementation in small and medium-sized pharmaceutical enterprises in China.This paper probes into the problems existing in the implementation of GMP in the small and medium-sized pharmaceutical enterprises in China, and on this basis, puts forward some policy suggestions for improving the implementation of GMP in the small and medium-sized pharmaceutical enterprises in China, and provides a reference for improving the implementation level of the drug GMP in our country.To provide development ideas for existing small and medium-sized pharmaceutical enterprises in China to overcome the crisis and meet the challenges.
【学位授予单位】：山东中医药大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：F273.2;F426.72

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