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