Application Of Quality Risk Management In The Production Of Biological Products

The theory and methods of risk management has a long history,but the application in the medical field was very late,especially in the field of Chinese medicine field?With the implementation of China's GMP(2010 version),the risk management was bring into regulations specifically,each enterprise according to the regulations also maked the risk assessment,but the implementation situation was very bad,the abuse of risk management often happen,and risk management becomes the "beautiful lies".Therefore,research on risk management is of great importance for pharmaceutical companies.In this paper we have studied the application of quality risk management in the production of biological products,the risk points in the process of production are summarized and the corresponding risk management measures are put forward,at the same time we combine the concrete example of produced products of the company,the use of FMEA method is applied to quality risk management,which provides the train of thought for quality risk management.First of all,the concept of quality risk management,process and some commonly used risk assessment tools are introduced,and its advantages and disadvantages of various risk assessment tools are described,thus it is benefit for the evaluator to select the appropriate assessment tools based on the specific situation.Secondly,from raw material,seed bank,fermentation cultivation,separation and purification,excipients,product preparation,the primary packaging,shipment and cold-chain transport,we identify potential risks in the process of production and take corresponding measures.Again,we list the concrete example of e.coli fermentation production process of the company,use the method of FMEA,from severity,possibility and detectability,we give them the degree of risk and score respectively,and then calculate the RPN,to determine the overall level of risk,and then according to the degree of risk to take different measures.Finally,we list the risk management in the application of quality system,and give a case study of the change control,listing the change control process and the risk assessment in the process of change control,and formulate action plan according to the results of the assessment.