基于质量风险管理的我国药品GMP检查研究

Research on GMP inspection in China based on quality risk management

目的将质量风险管理的理念和方法运用到我国GMP管理非常必要,我国GMP检查将依风险发起,建立统一规范的质量风险管理模型将有助于我国GMP监管的发展和完善。方法首先,介绍了质量风险管理;然后,分析了几个典型国家和地区质量风险管理在GMP检查中的应用情况,同时分析了我国GMP的发展和现状,依据质量风险管理的原则提出了对策建议。结果与结论我国应该出台具有指南性的质量风险管理文件,从企业自身和监管部门对风险进行识别和评估,根据风险评估确定检查时间和频率。建立药品全生命周期风险管理模型,同时加强国际间的合作,签订国际GMP互认协议。

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.