The Optimization Research Of YN Company Drug Production Quality Management System

Since the 98 edition of Good Manufacture Practices (GMP) has been implemented, the quality management of China’s pharmaceutical industry has experienced from scratch, and from there to the continuous progress of a process. But from an overall point of view, China’s pharmaceutical production enterprises is still in small, the pattern of good and bad, and the implementation of the GMP started too late, resulting in the quality management level of the industry of medicine production has lagged far behind in the developed countries in Europe and the United States. State Food and Pharmaceutical Administration in March 2011 1, announced a new form of GMP (Good Manufacturing Practice of 2010 Edition) and started in March,1,2011 officially, more stringent than the 98 edition GMP standard, more to improve, to pharmaceutical enterprises quality management requirements and a new level, the pharmaceutical industry ushered in a new round of reshuffle, large pharmaceutical companies to get the chance to gobble up smaller companies continue to grow, but also have the potential to the reef is not up to the new version of the GMP requirements and perish; production of small and medium enterprises has some problem with the pressure of how to survive or re-integration.YN company as one of China’s traditional Chinese medicine industry in the first echelon of the enterprise, main production YN series of varieties, preparation for external use, liquid and solid oral preparation, liquid oral preparations, injection, chemical raw material medicine and so on, in accordance with the new version of the GMP Specification for production and quality management, and through the 2010 edition of the GMP certification. because the new GMP has more standards, combine with several problems appeared in the progress of management of own quality, YN company must be on quality improvement for strategic thinking and prevent all kinds of difficulties, then give products more force to compete with others and promote the progress of enterprises development.The in carries on the analysis to the existent problem of YN company pharmaceutical quality management system in the foundation, total quality management, fish bone diagram, PDCA cycle model and many other methods were used, and combined with the real situation in YN and standards of GMP, then obtained the YN company pharmaceutical quality management system compliance optimization and continuous improvement is necessary. Then, the analysis of the causes of the problems in all aspects of pharmaceutical production, gave out some valuable idea and plans of many works. The results of this study have practical significance and value to ensure product quality and people’s safety, quality management and quality improvement for other domestic pharmaceutical enterprises has certain reference significance.