论文部分内容阅读
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 effect analysis (FMEA) in tablet process validation and to reduce the risk of validation. Methods FMEA was applied to process validation of dextromethorphan hydrobromide tablets, analyzing key influencing factors in the production process, assessing the impact of key factors on product quality, identifying risk levels, and developing risk control measures. As a result, the value of the risk priority coefficient (RPN) decreases after verification, reducing the quality risk. Conclusion FMEA can be effectively used in the risk assessment of tablet process validation and reduce the risk of production quality.