Quality Risk Management In Drug Circulation Section

As a special commodity, drug is used to prevent and cure of disease, diagnosis and keep health, its quality and safety have a close relationship to the health and safety of the public. Drug circulation is the link between drug manufacturer and final consumer, so it is extension of drug’s good manufacturing and quality assurance.With the emergence of some serious adverse drug events(ADE) in recent years, the public pays more attention on drug risk management during the circulation, besides drug manufacturing and administration of its safety. In2011, the concept of drug quality risk management was introduced to "Good Supplying Practice"(GSP)(draft). From then, GSP requires complete implementation of drug quality and risk management in the whole process of circulation.Drug quality&risk management is a systematized process, including identification, analysis, evaluation, explore the potential risks and make summary on how to control the risks; also has to review, examine and communicate on the results of control.Drug circulation is a complicated process and system, by studying the circulation entity, flow of drug circulation and characters of drug circulations, to analyze the problems existing in drug circulation industry:there are many problems on drug circulation industry, each circulating process, medical institution, Center for disease control, rural drug consumption, based on above problems revealed in drug circulation, conduct detailed quality&risk assessment, and also suggest on quality control methods.By studying on the subject and the latest regulation for drug circulation, give suggestions on establishing quality&risk management, standard the organization and system of quality&risk management during drug circulation, establish quality&risk management process according to its characters, and introduce this system to daily management process to avoid the drug risks.