我国新版GMP已强制推行无菌工艺模拟试验。本文从模拟试验的最差条件设计、抑菌因素、试验记录、环境监测、密封性测试和试验评价等方面进行分析,并结合实例探讨了非最终灭菌药品培养基灌装试验的常见问题和应对策略,以期提高制药企业的无菌生产工艺验证水平。 China’s new version of GMP has forced the implementation of aseptic process simulation test. In this paper, the worst conditions of simulated experiments design, antibacterial factors, test records, environmental monitoring, tightness test and test evaluation and other aspects of analysis, and with examples of non-final sterilization medium media filling test common problems and Coping strategies, with a view to improving the level of verification of aseptic production process of pharmaceutical companies.