Discussion On Application Of Risk Management In Management Of Small Volume Injection Production

GSP is the basic rule of the drug quality management process, which is a set of systemic, scientific management procedures designed for preventing accidents by controlling all the possible factors in the circulation links. Its core is to restrict the activities of enterprises through the strict management, control the quality in the whole process, track effective of drugs sold, and assure to provide qualified drugs to users. GSP has been accepted by many countries in the world, at present, and many countries and regions in the world are in the implementation of GSP certification. GSP is a mandatory supervision in China, and it has achieved initial achievements since the GSP certification work started in our country. GSP has a realistic meaning in improving the management of enterprises and the quality of medicines, and ensuring the people’s safety.Anhui province is a big province of pharmaceutical circulation. After a few years of the GSP certification, remarkable achievements has made in drug circulation supervision in Anhui province, which is mainly manifested in that:The structure of the pharmaceutical industry in Anhui province has been optimized and adjusted, and the pharmaceutical distribution market has been regulated. By improving the pharmaceutical industry market access threshold, and strengthening the intensification, scale and the overall competitiveness, the quality level of support in the field of drug circulation is fundamentally improved and quality risk is minimized,which ensure the people’s safety and effectiveness of drugs.This paper conducted researches on GSP certification management model in the various provinces and cities studied by using methods of empirical investigation, statistical analysis and others. The problems existing in the process of the implementation and certification of the amended GSP in AnHui province and its causes were analyzed. The study made some suggestions to perfect the management of GSP certification in Anhui province as followings:improving the certification and the management framework, strengthening supervision after certification and the effective integration of the authentication management and administrative.The new revision of GSP implemented from June 1,2013, the new revision of GSP improves the medicine circulation industry access threshold, is conducive to speed up the adjustment of industrial structure of China’s medicine circulation, enhances the enterprise the intensive, large-scale level and the comprehensive competitiveness, its implementation is also in China’s medicine circulation reform in the field of basic work. This paper summarizes the existing problems of GSP in Anhui province since the implementation of the new revised pharmaceutical trading enterprise, and analyze the reasons for its existence, in-depth pharmaceutical trading enterprises, quality management and related links, found common weaknesses enterprise certification process, contribute to the steady advance new revised GSP, and effectively improve the quality and level of management the quality of drugs, so as to enhance security capabilities, and promote sound and rapid development of pharmaceutical economy.