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Research On The Implementation Of GMP In The Small And Medium Sized Pharmaceutical Enterprises In Chinat

Posted on:2014-01-20Degree:MasterType:Thesis
Country:ChinaCandidate:Y WangFull Text:PDF
GTID:2269330425958095Subject:Drug Analysis
Abstract/Summary:PDF Full Text Request
Medicines are special products made to safeguard people’s lives and health. The qualitymanagement of medicines is of special importance. GMP can ensure the quality of medicines andsafeguard the safety and effectiveness for the people. In order to fulfill this goal, GMP makes surethat the whole process of drug production is under normative management and all the pharmaceuticalcompanies follow the systematic and scientific industry formulas and the strict code of good businessconduct.GMP was introduced into China in the early1980s, and this is twenty years later than the U.S.pharmaceutical industry. GMP in China has gone through four stages of development, which isPreparation stage, embryonic stage, stage of infancy, and perfecting stage. After three decades ofdevelopment and evolution, the great progress China has achieved in GMP is there for all to see. Dueto the implementation of GMP, the quality of medicines has been assured to a certain extent, and theoverall quality of pharmaceutical companies has been greatly improved. But there are still manyproblems on the implementation of GMP in China. If these problems could be solved properly, thedevelopment of China’s pharmaceutical industry will be seriously hindered.After a long period of hard work and development, China’s GMP is similar to that of manydeveloped countries judging from the text. But in Implementation level, there are still significantdifferences between them. The Implementation problem is especially prominent in small andmedium-sized pharmaceutical companies which account for a large proportion of all pharmaceuticalcompanies. To a large extent, the Implementation condition in small and medium-sizedpharmaceutical companies determines the quality and safety of medicines in China. Theimplementation problem in small and medium-sized pharmaceutical companies has become a keyelement in the quality and safety of medicines and the most difficult issue in the supervision andmanagement of medicines. Meanwhile the Implementation condition also determines the Long-termstable development to these companies. It surely has important theoretical and practical significanceto find out an implementation mode which is Suitable for China’s national conditions. It will alsogreatly ensure the quality and safety of the medicines in china, and promote the healthy developmentof China’s pharmaceutical industry.From a managerial point of view, this paper studied the4M essential factors, analyzed the advanced Knacks of some foreign nations, and studied the Implementation condition and problems insmall and medium-sized pharmaceutical companies. And based on all these analysis this paper putforward a series of policy suggestions to improve the Implementation of GMP for small andmedium-sized pharmaceutical companies. This study can provide references for the promotion of theImplementation of GMP in china. This study can also provide ideas for development of small andmedium-sized pharmaceutical companies to overcome the crisis and meet the challenges.
Keywords/Search Tags:Drug GMP, effective implementation, small and medium-sized pharmaceuticalenterprises
PDF Full Text Request
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