药厂GMP认证工作中风险管理的应用分析

目的 探讨风险管理在药厂《药品生产质量管理规范》(GMP)认证工作中的作用.方法 在药厂GMP认证审评工作各环节应用风险管理工具,对企业审评各环节进行排查,根据评估风险值确定企业现场检查时间,并运用风险管理工具评价企业缺陷项目的改正效果.结果 风险管理的应用可提高药厂GMP认证的工作效率,规范工作程序,合理分配资源.结论 风险管理在药厂GMP认证审评工作中可科学准确的对待审评企业做出评价.

Application analysis of risk management on Pharmaceutical GMP certification

Objective To discuss the effect of risk management in pharmaceutical production quality management standard (GMP) certification. Methods In the risk management tools all aspects of the pharmaceutical GMP certification review application, investigation of the various aspects of enterprise evaluation, according to the risk assessment to determine the value of the on-site inspection of the enterprise, and the use of risk management tools to evaluate enterprise project defect correction effect. Results The application of risk management can improve the work efficiency of GMP certification, standardize the working procedure and allocate the resources reasonably. Conclusion Risk management in pharmaceutical companies GMP certification review, scientific and accurate evaluation of the evaluation of the enterprise.