Investigation Of The Application Of Risk Management In Drug

The quality of drugs directly related to the quality of people's health and safety. In recent years a great many disastrous events caused by drug production errors has brought great losses to the society. How to effectively guarantee the quality of medicines and prevent the recurrence of the quality incident of the pharmaceutical production, which has become a major task for the government regulatory agencies.As a scientific and effective methods of risk prevention and control.In recent years, some countries or areas has gradually applied risk management to pharmaceutical production supervision and management work. Especially in the United States and the European Union, the relevant documents have been developed and introduced to guide the work of risk management in pharmaceutical production. The implementation of drug risk management in China was late, the implementation in the field of pharmaceutical production supervision is still at the exploratory stage. Although some areas have introduced risk management theory in the pharmaceutical production supervision, it was superficial, and there is no systematic analysis about the basic procedures and methods of drugs production risk management.In this paper, the theory of risk management related to the full study, based on the theory of risk management will be introduced to the supervision of drug production, proposed the risk management in pharmaceutical production and methods of the basic procedures. In addition, a number of suggestion contribute to strengthening the risk management of pharmaceutical production was proposed, and strive to the adoption of such a systematic analysis and conclusion, to further strengthen the supervision and management of pharmaceutical production and quality of the risk of drug prevention, for the current supervision and management of pharmaceutical production in China provide a useful reference.The main contents of the dissertation includes: (1)The introduction of the theory of the risk and risk management,including bthe definition, aracteristics, classification and the constitutive factors of risk.(2)The introduction of the developing overview of the native and abroad,as well as the applications of the theory of risk management in the insurance,finance,business management and government administration.(3)Research the theory of drug risk management,including the classification of drug risk and the concept of drug risk management.as well as the theory and practice of risk management introduction in the native and abroad.(4)Research the application of the theory of risk management in the field of drug producing supervision.Combined with risk management theory and pharmaceutical production,propounding the basic procedures and the technical methods of the risk management in pharmaceutical production.(5)Proceeding from the view of government regulation,and making some advice to strengthen risk management in pharmaceutical production.For example, enhance the awareness of the risk in pharmaceutical production,constructing a strong commanding mechanism in the incidents of pharmaceutical manufacturing risks,establishing a perfect information feedback mechanism of the drug production risks and a whole process of risk management mechanism,in order that to carry out the effective supervision of drug production further.