Research on GMP inspection in China based on quality risk management
Objective To apply the concepts and methods of quality risk management to China's GMP management,and to establish a unified and standardized quality risk management model for the development and improvement of China's GMP supervision.Methods & Results Quality risk management was first introduced,and then the application of quality risk management in GMP inspection in several other countries and regions was investigated.Meanwhile,the development and current situation of China's drug production quality standards were analyzed so as to put forward some suggestions according to the principles of quality risk management.Conclusion China should issue guidance documents on quality risk management,which enable enterprises and the regulatory authorities to identify and evaluate the risks,and determine the inspection time and frequency according to the risk assessment.Besides,a drug life cycle risk management model should be established.At the same time,international cooperation must be strengthened by signing an international GMP mutual recognition agreement.
万方数据
维普
