Research On Six Sigma Application In ZSHT Pharmaceutical Company

Combining the Six Sigma management theory and the specific situation of the ZSHT pharmaceutical company,the thesis targets on the problems in the company’s practical production process,focusing on the Six Sigma improvements for “BG particles”,which is the key product of ZSHT,and proposes proper suggestions and solutions.Thesis starts from the requirements of GMP(2010 version),after reviewing the development and application of GMP in Chinese pharmaceutical production,the similarities and differences between the 1998 version and the 2010 version are studied.Then the existing problems in the pharmaceutical companies that meet GMP(1998 version)are analyzed,leading to the proposing of the necessity and urgency to improve the quality management of the pharmaceutical companies.Through the analysis of the present situation of domestic and foreign pharmaceutical industry,as well as domestic applications of the Six Sigma management methods,the thesis identifies the problems that the ZSHT company confronts.Based on the DMAIC Model of Six Sigma,the production flow of BG particles are analyzed,defined every index,according to which the measurement and analysis are preceded.And then the reasonable improvement suggestions are put forward,which realize the continuous control of raw materials,processes and products,therefore,the quality management system can be completed successfully.Furthermore,through this study,the ZSHT company has improved the production process,raised new requirements for specific equipment,established new employee training system and document arrangement system,in order to ensure the achievement of Six Sigma.