Research On Application Of HACCP System In Quality Risk Management Of Traditional Chinese Medicine Injection

Because of the short development time and complex composition of traditional Chinese medicine(TCM) injections, factors that causing the risk involved in all aspects of raw materials, production and clinical use. To establish a complete and effective management system to protect the safety of traditional Chinese medicine injection is the primary goal of the safety management. April 24th-25th 2008, the"high-risk drug Seminar Series - traditional Chinese medicine injection Risk Management Seminar"held to promote enterprise's understanding and awareness of the risk management of TMC injection, and to promote enterprise to establish"rug Risk Management system". The establishment of Risk management system of TCM injections should not be limited to regulatory agencies and pharmaceutical manufacturers, we should also take the production of raw materials and irrational drug use in patients and medical institutions into consideration, only implement the risk awareness to all aspects of TMC injection, can we get the best results. TMC injection should establish a comprehensive and systematic quality risk management system. Through raising the capacity of quality risk management to reduce the risk of using TMC injection, and guarantee the safety of clinical use of drug.Start from the pharmaceutical quality risk management theory, The article conducted a comparative study of the status quo of quality risk management in Europe, the United States and China, analysed the management status quo and risk factors of TMC, analysed the feasibility of applying HACCP into the quality risk management from the aspects of policy,technology, and economic,and finally establish the quality risk management of HACCP system . Details are as follows:(1) Introduction of the drug quality risk management. Though comparative study of the status quo of quality risk management in Europe, the United States and China, summed up the necessity of implementing drug quality risk management and introduced the process of applying HACCP into drug quality risk management.(2) Introduction of HACCP. Introduced the concept, the origin, the development, the characteristics, the basic principles and implementation status of HACCP. Conducted a comparative analysis of the differences and relations between HACCP and GMP, SOP.(3) The quality risk management of TMC injection. Introduced the development and management status quo of TCM injections and analysed the quality risk factors.(4) Introduced the feasibility of applying HACCP into quality risk management from the aspects of policy, technical, economic detailly, learned the experience and effect of HACCP in other industries. Described the practical significance of applying HACCP into quality risk management of TMC injection.(5) The application of HACCP system in quality control of Chinese herbal medicines. Seven basic principles of the HACCP is used in planting, production process of Chinese herbal medicines, to analyse the potential hazards in planting and production process, to establish a HACCP plan table,to determine the critical control points?control limits?the monitoring object?methods?frequency and personnel,determine the record and file that need to be preserved.(6) The establishment of HACCP system in traditional Chinese medicine injection manufacturer. First, the pre-steps of the HACCP management system - set up a HACCP team, product description, determine the intended use and suitable patients, describe the production flow chart,confirm the flow chart at the scene: then combined with the basic principles of HACCP, conduct Hazard Analysis,determine the critical control points,establish the critical limits for critical control points, establish monitoring system for monitoring critical control points,establish corrective measures taken when the critical control point is out of control, establish a system that can prove that the HACCP system is effective, establish a system to record the HACCP system.(7) The application of the HACCP system in the clinical use of traditional Chinese medicine injection. According to the process of clinical use of TCM injection to analysis the potential hazards that based on decision points and decision tree, determine the critical control points in clinical use, establish the HACCP plan table in clinical use.Through establishing HACCP management system in the Production of Chinese herbal medicines and TCM injection, and in the clinical use of TCM injection, to control the risk factors in raw material?product and clinical use effectively. Strengthen the quality management from all the aspects of raw materials, production, storage, transport and use to improve the capacity of risk management, to avoid the TCM injection risk events occur, to ensure the safety and effectiveness of the drug .