失效模式和影响分析在原料药工艺验证中的应用

Application of Failure Mode and Effects Analysis in Active Pharmaceutical Ingredient(API) Process Validation

关键词:  失效模式和影响分析  原料药  工艺验证  风险管理

Key words:  failure mode and effects analysis  active pharmaceutical ingredient(API)  process validation  risk management

摘要:

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。

Abstract:

OBJECTIVE To explore the application of risk management tools in the API process validation, using failure mode and effects analysis (FMEA), evaluate the key process parameters, reduce the risk of validation. METHODS FMEA applied to the process validation of API, according to the size of the RPN value, to determine the key process parameters and risk control measures. RESULTS By implementing and tracking process operation control measures, and once again calculate RPN value, reduced than before validation, reduced the risk of process deviation occurs. CONCLUSION Quality risk management is applied to the API process validation, which can effectively improve the pertinence, reduce the system risk of the production quality, will be conducive to smooth running of daily commercial production, improve production efficiency.