Research On Quality Risk And Supervision Of Pharmaceutical Manufacturers

The drugs are a special commodity for mankind to maintain a healthy indispensable.Drug safety and risk management has become an important part of the supervision of the national government departments.With drug quality and safety problems happened frequently,the Chinese government has become even more emphasis on drug quality and safety issues to strengthen drug supervision and management,meanwhile the concept of risk management applied to the supervision and management.This paper argues that the drug quality risk management is an important part of the drug supervision and management,besides it requires not only a clear standard system for relying but also specific organizations and departments need to operate under the Drug Administration regulations and put into practice.This article is based on reviewing of the general theory of risk management,the quality of all aspects of the pharmaceutical manufacturing process risk assessment and to identify the key risk control point,Drug quality risk management,regulatory policy framework,combined with China's national conditions provide important reference for drug supervision and management departments to strengthen and expand drug risk management.This article focuses on the following aspects of the analysis:(1)To analysis the potential quality problems in the pharmaceutical manufacturing process in China and its reasons through literature review.Materials issues led to the events of the "poison capsule quality management chaos led to the events of" Let the two drugs",production management confusion led to the" Xinfu "incident" methotrexate "event,storage,transport due to improper the Wandashan" event.(2)Description of the development of pharmaceutical production enterprise quality management theory,the necessity of the implementation of quality risk management,quality risk management principles,procedures,and its relationship with the drug regulatory.(3)The use of risk management theory analysis of the entire process of the pharmaceutical manufacturing enterprises in China's pharmaceutical manufacturing process,in turn risk identification,risk analysis,risk assessment,and risk control,the potential risk of the fishbone diagram classified analysis(4)Summarizes the general common dosage form pharmaceutical production process,the use of systems analysis theory and Production diagram is drawn,the formation of risk management tools.According to the literature,respectively,in terms of materials,personnel,technology,equipment,environment,process detailed summary of the corporate risk in the pharmaceutical manufacturing process point of flow charts,checklists and the fishbone diagram to facilitate decision making.(5)With the use of risk analysis tools HACCP and HAZOP theory,common dosage form pharmaceutical production quality risk critical control point.Possible the design and analysis of a questionnaire for possible problems listed pharmaceutical production and quality risk management,with the statistical analysis tool SPSS software and Pareto chart analysis of the survey results to preliminary design and to determine pharmaceutical production and regulatory quality risk control points.(6)With the organizational innovation theory based on the critical control points of enterprise quality risk regulatory strategy,we can raise the related questions about the risk of China's pharmaceutical production enterprise quality regulatory strategy that based on the analysis of the causes and risks of pharmaceutical production enterprise quality risk control point,compared to our current pharmaceutical production and quality management system and with reference to the experience of the European and American pharmaceutical risk management.