Research On Quality Control And Improvement Of ZSHT Pharmaceutical Company Limited

The drug as a special commodity for the prevention and treatment of humandiseases, its quality is directly related to people’s health and safety. Especially withthe rapid development of economic and society, increasingly high demand isrequested by the public and regulations about drugs are more and more strict.However, since twenty-first century, many medical events and adverse events aboutdrugs have occurred, which cause the social concern and awareness ofpharmaceutical companies. In the drug manufacturing process, the GMPspecification is just the basic guarantee of product quality, what the majority ofpharmaceutical companies expect to seek is that how to achieve effectivequality control and risk prevention measures in the process of manufacturing.Therefore, how to effectively guarantee the drug quality is an important issue whichevery pharmaceutical manufacturing enterprise needs to solve.This thesis firstly introduces the current situation of the pharmaceuticalindustry, pharmaceutical quality and quality management theories, as well asthe development process of GMP, and expounds the importance ofstrengthening drug quality management. Secondly, combined with the existingproduct, choose the representative tablet as the breakthrough point, make acomprehensive analysis of its quality characteristics to find out the key factorsinfluencing its quality index in the stages of the product realization. Finally, on thebasis of actual production, combined with the actual situation of the new version ofGMP certification which is proposed, put forward the main factors affecting thequality of drug in the life cycle, further analysis and formulate specific measures forimprovement.Through the research in this thesis, it is hoped that it provides a help inthe quality management and certification of the company, and inspire the qualitymanagement of other companies.