Research In Quality Risk Management Of Tasly Jenner Pharmaceutical Company

With the enhancement of drug safety concerns, people pay more attention toconstruction of the drug quality risk system and risk management in pharmaceuticalproduction, circulation and use.High quality drug is the mission of eachpharmaceutical manufacturer。In recent years, it appers some drug quality problems,drug manufacturers should reduce theadverse loss of drug quality risk, and ensure thequality of medicines.Therefore，it is so important for pharmaceutical manufacturer toconstruction and improvement the quality risk management.It is research on TaslyJenner’s quality risk management system by quality risk management tools such asFMEA, the fishbone diagram and process capability index, and make somesuggestions on improve the quality risk management.It is depth study of TaslyJenner’s quality risk management system by the literature index method, actionresearch, the empirical analysis of research methods.The article has six parts.The firstpart is introduction,includes background、practical significance、methodology、framework structure and brief introduction of Tasly Jenner。The second part isoverview of quality risk management theory, introduces the theory involvedin the study， includes evolution of risk theory,conceptual analysis of medicalquality risk management and the procedures of quality risk management, etc.The thirdpart is analysis of China pharmaceutical industry, introduces the development ofChina’s pharmaceutical industry, the basic characteristics of pharmaceutical industry,the development of China pharmaceutical company’s quality risk management andproblems.The fourth part is quality risk management system construction inpharmaceutical company, includes the procedures of quality risk management,qualityrisk assessment and control,and quality risk management tools.The fifth part isintroduction of Tasly Jenner’s quality risk management system,introduces the appliedof typical tools, such as FMEA, fishbone diagram, and process capabilityindex.The last part is conclusion,though the study of Tasly Jenner’s quality riskmanagement system,it gives some revelations for pharmaceutical companies in thequality of risk management.