Study On The Risk Management Application In The Technical Evaluation Of Pharmaceutical GMP Certification

In30years of reform and openness with rapid development of economy China has changed into the third medicine market in the word. Meanwhile the public raises higher reqirements in safety and efficiency of medicine. It becomes urgent that How to use finite supervision resources with science and high effectiveness to eliminates public safety events due to medicine quality and to guarantees medicine quality.Now risk management supplies an effective ways and means. What Risk management emphasizes is prospective precaution action and investigates main causes to problems,so it makes dicisions appropriateness and effective to avoid blindness. For the technical review of pharmaceutical GMP certification, through risk management, you can effectively find the key links and steps of influencing the quality of medicines from various links,you can reasonably configurate the limited administrative resources, and timely and accurately understand the running condition of production and quality management, get scientific, systematic evaluation of enterprises, also supply safe and effective protection to the public medication security.The study is divided into four parts, the first chapter describes the background, methods, and contents of it. The contradiction has become increasingly prominent between Pharmaceutical manufacturing enterprises in China "multiple and small, scattered." and the weakness of supervisory resources, and results in frequent drug injury events. How to utilize the limited supervisory resources, reduce the risk, control drug quality, has become first task of pharmaceutical administration. Through research on risk management theory, the study attempts to use risk management tools in all aspects of the technical review of pharmaceutical GMP certification to make it much more systematic, high performance, scientific, standardized.The second chapter overviews on the basic concepts, principles and procedures, methods and tools for risk management.In chapter III four main components of technical review of pharmaceutical GMP certification are separately studied. Data Review Phase, mainly with CHECK SHEET, troubleshooting risk points from enterprises. and according to respective risk situations, respectively grant five conclusions:Returned, Additional data, Implementation with telephone, Site verification by inspection group and Qualified.The second step, develop inspection plan. Main point is, to enterprises with more severe risks the inspection should be more concerned about. First to rate the risk assessment to the different types of enterprises, Based on value-at-risk, determine the site inspection time; The third link, site inspection stage. With the Freeze-dried Powder for Injection and Oral Liquid Preparation workshop as an example, with the HACCP (hazard analysis and critical control points) method to identify critical control points, determine key-checking elements, and last form a complete inspection list; The Forth link, it is the period to review the inspection report and correct report. Study focuses how to use risk management tool-FMEA (failure mode effects analysis) for evaluation to effect of correction of the defective items. Through the rate to defect items before and after the correction in the severity, frequency, detectability calculate RPN(the Risk Priority Number), so as to determine whether the risk has been eliminated or controlled.The fourth chapter summarizes the study. Main shortcomings of it are: risk of products considered less, some research is not in-depth, integration of drug supervision resources is not considered, and so on; In risk management implementation personnel training and all level of risk communication should be done more; It is much more significance that the study can make drug GMP certification improve efficiency, reasonably distribute supervision resources, standardize work program, and evaluate enterprises accurately. The study also has some of reference in implementation of risk management to enterprises. Finally it provides direction for further research.