The Research On The Quality Risk Management Of The Shandong NH Pharmaceutical Company

In recent years, China’s pharmaceutical industry is developing rapidly, increasing the number and size of pharmaceutical enterprises, Chinese become the world’s largest emerging pharmaceutical market. At the same time, with the development of economy,improve people’s quality of life, people’s health and the health of the attention constantly enhanced. The drug occupies an irreplaceable position in people’s life, the quality of drug influences people’s health, even life safety. However in recent years due to the increase in the types of pharmaceutical products, increase the yield, the drug adverse reaction events is also often seen in the newspapers, causing public concern and worry. In the 1980 s, developed countries had already started to quality risk management research, in order to strengthen the management of drug quality,developed countries established drug regulatory agencies for pharmaceutical production carried out daily quality control, and formulated the corresponding pharmaceutical quality management specification constraints of pharmaceutical companies in the production activities. The implementation of quality risk management in our country is late, the quality risk management in the pharmaceutical industry is in the initial stage. In 2011 a new version of the GMP first drug quality risk management into the pharmaceutical quality management specification and requirements of the drug quality risk management throughout the drug life cycle each stage and to make it more effective to identify potential quality risk, to avoid quality problems and make better drugs for human life and health service. But in the actual operation, quality risk management into the pharmaceutical enterprises is still a weak link, pharmaceutical enterprises special needs to establish a set to conform to the quality and risk management system of its own characteristics, in order to improve the enterprise of drug quality and overall operational efficiency.Through the collection and collation of the literature, the author reviewed the literature on quality risk management at home and abroad, and the quality risk management of pharmaceutical enterprises in our country is still in the initial stage. In the drug quality, drug risk, comprehensive quality management and quality riskmanagement on the basis of theoretical research, the author pharmaceutical company in Shandong NH for object, first on NH Pharmaceutical Co., Ltd. Shandong quality risk factors were analyzed. The author designed NH Pharmaceutical Co., Ltd.Shandong quality risk influence factor questionnaire, to employees as the research object, and to investigate the results of statistical analysis, the three dimensions of Shandong NH company quality risk, a factor of 15. Three dimension is environmental factor, enterprise factor and drug factors. Secondly, the status quo of quality risk analysis of Shandong NH pharmaceutical company. The influence factors as the basis,combined with theory of life cycle of drug, the drug research and development stage,production stage and service stage were analyzed, and the enterprise culture, staff training, quality management system construction and information management of quality risk. Finally, according to the life cycle theory and the influence factors,constructing the system of quality risk management of Shandong NH pharmaceutical company. The system consists of organization structure, staff training, regulations,design risk questionnaire, feed-forward control, provide a powerful guarantee for Shandong NH pharmaceutical company the implementation of quality risk management.