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目的探索风险管理工具在原料药工艺验证中的应用,使用失效模式和影响分析(failure mode and effects analysis,FMEA)评估关键工艺参数,降低验证风险。方法将FMEA应用于原料药的工艺验证,根据风险优先数(risk priority number,RPN)值的大小,确定关键工艺参数和风险控制措施。结果通过实施和跟踪工艺操作控制措施,再次计算RPN值,较验证前减小,降低发生工艺偏差的风险。结论质量风险管理应用于原料药工艺验证,可有效地提高针对性,降低生产质量的系统风险,将有利于日常商业化生产的平稳运行,提高生产效率。
Objective To explore the application of risk management tools in the validation of APIs and to evaluate the key process parameters using failure mode and effects analysis (FMEA) to reduce the risk of validation. Methods FMEA was applied to the process validation of APIs. According to the value of risk priority number (RPN), key process parameters and risk control measures were determined. Results By implementing and tracking process control measures, RPN values were again calculated, which were lower than before verification to reduce the risk of process variations. Conclusion The application of quality risk management to the validation of APIs can effectively improve the systematic risk of targeting and reducing the production quality, which will benefit the smooth operation of daily commercial production and increase the production efficiency.