本文選題：藥品GMP　切入點：有效實施　出處：《山東中醫(yī)藥大學》2013年碩士論文

【摘要】：藥品是保證人民生命健康的特殊產(chǎn)品，藥品質(zhì)量管理具有特殊的重要性。藥品GMP通過對藥品生產(chǎn)全過程進行規(guī)范管理，確保制藥企業(yè)遵循科學、系統(tǒng)的行業(yè)準則和行為規(guī)范，保證藥品質(zhì)量，維護人民群眾用藥的安全有效。 藥品GMP于上世紀80年代初引入我國，與美國制藥行業(yè)相比晚了二十多年。我國藥品GMP經(jīng)歷了四個發(fā)展階段，即準備階段、萌芽階段、起步階段、發(fā)展完善階段。經(jīng)過三十年的發(fā)展演變，我國藥品GMP取得的進步是有目共睹的。通過實施GMP，藥品質(zhì)量得到了一定程度的保障，制藥企業(yè)的綜合素質(zhì)得到了很大的提升。但是，還應(yīng)當看到，我國GMP的貫徹實施還存在許多問題，這些問題不解決，將嚴重阻礙我國制藥工業(yè)的發(fā)展。 經(jīng)過長期的努力和發(fā)展，我國藥品GMP在文本上已經(jīng)同發(fā)達國家的GMP相差無幾，但在實施層面上，我國GMP同發(fā)達國家GMP還存在著較大的差距，特別是中小型制藥企業(yè)的GMP實施問題更為突出。我國制藥企業(yè)當中，中小型制藥企業(yè)占據(jù)很大的比重，中小型制藥企業(yè)GMP的實施狀況在很大程度上決定著我國的藥品質(zhì)量，決定著人民群眾用藥的安全程度。中小型制藥企業(yè)GMP實施中存在的問題，成為影響藥品質(zhì)量的關(guān)鍵和監(jiān)督管理的難點。與此同時，中小制藥企業(yè)GMP實施問題，也關(guān)系到中小型制藥企業(yè)的長期穩(wěn)定發(fā)展。所以，探索適合我國國情的中小型制藥企業(yè)藥品GMP實施模式，對于提升中小企業(yè)GMP實施水平，保證人民群眾用藥的安全有效，，促進我國制藥企業(yè)健康發(fā)展，具有重要的理論意義和現(xiàn)實意義。 本文從管理的角度，對藥品GMP管理的4M要素和國外中小型制藥企業(yè)藥品GMP管理的先進經(jīng)驗進行研究,弄清我國中小型制藥企業(yè)GMP實施的現(xiàn)狀，探討我國中小型制藥企業(yè)GMP實施中存在的問題，并在此基礎(chǔ)上,提出改進我國中小型制藥企業(yè)GMP實施的政策建議，為提升我國藥品GMP實施水平提供參考，為我國現(xiàn)存中小型制藥企業(yè)克服危機迎接挑戰(zhàn)提供發(fā)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.
【學位授予單位】：山東中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2013
【分類號】：F273.2;F426.72

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