A Study On The Management Of Quality Risk In Drug Outsourcing Production

In recent years,with the implementation of innovation-driven strategy,China has been looking for new economic growth points.Due to the continuous development of science and technology and the deepening of economic globalization,the competition between enterprises has been diversified and increased gradually,and supply chains has become the key factor influencing competition.Pharmaceutical industry,as an important part of driving GDP growth,will bring more and more developing opportunities to the national economy while growing up.Pharmaceutical production outsourcing,which can enhance the core competitiveness of enterprises and realize the complementary advantages between pharmaceutical RD enterprise and manufacturer,is considered as a successful measure.However,there still exist many problems in the outsourcing of drug production because our country started late in this filed and till now the whole market is not mature enough.The quality of drug is related to consumers’ safety and has been the great attention of all fields.Therefore,this paper focuses on the drug quality risk in process of drug outsourcing production,and discusses the countermeasures to reduce the risk.In this paper,the quality risk problems in process of drug outsourcing production were studied basing on three aspects.Firstly the concept,service scope,advantages and necessity of drug outsourcing production were presented,along with current domestic and oversea situation,and the quality risk problems existing in the outsourcing process and their causes were pointed out and discussed.The countermeasures to reduce the quality risk of outsourcing production at three different time nodes,i.e.beforehand,undergoing and afterward,were studied from the micro viewpoint of enterprise risk management.The necessity and the defects of regulations on the practice of drug outsourcing production were also studied from the macro viewpoint of government control,and corresponding countermeasures to overcome the shortcoming were put forward.In addition,this paper discussed the way how to reduce the opportunism and moral hazard of outsourcing enterprises by designing contract parameters.Two kinds of control situations were analyzed,including centralized control when bilateral interests are same and decentralized one while both sides are not in the same interest body.Furthermore,based on a bilateral moral hazard in which both sides are “free riders” and a traditional unilateral moral hazard only existing on one side,bilateral moral hazard pre-pricing contract,traditional moral hazard pre-pricing contract and specified quality function contract were designed,and their effects on improving the quality of product were compared by means of assigning values to specific examples.Finally,the results showed that the above contracts can effectively reduce quality risk.