质量风险管理在非无菌原料药清洁验证评估中的应用

摘 要 目的：以质量风险管理为指导思想，使用失效模式和影响分析（FMEA），评估清洁验证整个过程的各个环节关键，降低风险。 方法: 将 FMEA 应用于原料药的清洁验证，根据风险优先数值的大小，确定清洁验证关键实施的风险点和风险控制措施。结果: 通过控制措施，获得最终风险评分以用于评估最终对产品质量或患者安全产生的影响。结论: 质量风险管理应用于非无菌原料药清洁验证，可有效地把控好清洁验证实施过程中的各个环节，提高针对性，降低实际生产过程中的质量系统风险，具有重要的指导意义。

Application of Quality Risk Management in Cleanliness Verification for Nonsterile Raw Materials

ABSTRACT Objective: To take quality risk management as the guiding ideology and use failure mode and effect analysis (FMEA) to evaluat the key of the whole process of cleaning validation which aimed to reduce the risk. Methods: FMEA was applied in the cleanliness verification of APIs. According to the risk priority values, the risk points and risk control measures were determined for the key validation of cleanliness verification. Results: Through the control measures, the final risk score was obtained to assess the impacts on the final product quality and patient safety. Conclusion:Quality risk management is applied in the cleanliness verification of nonsterile APIs, which can effectively verify all aspects of the process, improve the pertinence and reduce the quality system risks in the actual production process with important guiding significance.