Drugs Wholesale Quality Risk Management Reserch Of Shandong LS Company

Along with the development of the reform and opening up and social economy, our country’s pharmaceutical industry has been growing at a rapid speed. As an intermediate link of drugs production and consumers, Drugs wholesale enterprises also enter a new stage of development; In recent years there have been some serious adverse drug reactions/events(ADE) along with a rising trend, the paper also analyzes a few typical events involving drugs wholesale enterprises; At the same time, the current "Good Supplying Practice"(GSP) has far cannot satisfy the practical need to enforce "the risk of drug quality management", In order to comply with the form, Ministry of Health issued the new "Good Supplying Practice"(GSP) in2013, clearly put forward to quality risk management in the whole process of drugs circulation.Drug quality risk management is a systematic process, and the paper studies the theoretical basis, including total quality management, Good Supplying Practice and risk management. Effective quality risk management can guarantee the safety of drugs of the people, improve the core competitiveness of drugs wholesale enterprises, and also can provide quality risk management reference for pharmaceutical industry.Methods of the research includes information retrieval and theoretical review method, case analysis method, comparative analysis method, questionnaire survey method. In the process of risk analysis assessments,the paper uses two risk management tools, namely the check list method, failure mode and effects analysis.The paper analyzes quality risk problems of drugs,circulation industry, drugs wholesale business and the buying and selling link of shandong LS company, and enumerates several typical adverse drug events exposed by the quality problems. Using the checklist, failure mode and effects analysis in detail with the methods of risk assessment, the paper reengines quality risk management principles, system and process of drugs wholesale of shandong LS company for more effective, and put forward the reasonable effective quality risk management advice combining the characteristic of drugs wholesale and buying and selling process.Because fo drug quality risk management is a complex and systematic project, the paper needs to make quantitative risk assessment the quality of each link, and also need to verity and revis many measures and methods proposed in the pratical work; At the same time, enterprises needs that research be combined by theory and practice comprehensively and dynamiclly, therefore, further research direction is to develop total quality risk management (TQRM) system to cope with the complicated and changeable quality risk events or trends...