摘要
目的:采用相关风险管理工具对中药栓剂生产风险进行管理。方法:运用FMEA(失效模式和影响分析法)对中药栓剂生产过程进行风险管理。结果:分析中药栓剂生产过程中的风险因素,并制定相应的控制措施。结论:FMEA是一款行之有效的可前瞻性定性、定量的风险管理工具,能较好地控制生产中的风险。
Objective：To use risk management tool for the application of traditional Chinese suppository. Methods： FMEA （failure mode and effects analysis） was performed on the application in granulating process of traditional Chinese suppository. Results： Analyzed risk forctors in granulating process of traditional Chinese suppository, and developed a corresponding control measures. Conclusion： FMEA is an effective risk management tool which can be used for prospective and quantitative analysis, it can be controlled better the risk of granulating process.
出处
《中国药物评价》
2014年第6期356-361,共6页
Chinese Journal of Drug Evaluation
关键词
中药栓剂
生产过程
失效模式和影响分析法
风险管理
Traditional Chinese suppository
Granulating process
Failure mode and effects analysis
Risk management
