片剂工艺验证中应用失效模式和影响分析的风险评估

Risk Assessment in Process Validation of Tablets by Failure Mode and Effects Analysis

目的探索失效模式和影响分析(FMEA)在片剂工艺验证中的应用,降低验证风险。方法 FMEA应用于氢溴酸右美沙芬片的工艺验证,分析生产过程中的关键影响因素,评估关键因素对产品质量的影响,确定风险等级以及制定风险控制措施。结果验证结束后风险优先系数(RPN)值减小,降低了质量风险。结论 FMEA可有效用于片剂工艺验证的风险评估,降低生产质量风险。

OBJECTIVE To explore the application of failure mode and effects analysis（ FMEA） in the tablets process validation and in order to reduce the risk of process validation of tablets. METHODS Application of FMEA in the process validation of Dextromethorphan Hydrobromide Tablets,analyzed the key factors in the process of production,assessed their impact on product quality,determined the risk grades,and set up the risk control measures. RESULTS The results showed that risk priority number（ RPN） value decreased after process validation,indicating that the quality risk of product was reduced. CONCLUSION FMEA can be effectively used in the tablets process validation.