微生物风险评估 – 无菌灌装生产线

AS-Advisory-Paper_110117_Page_6.jpg对分级、风险评估、监控计划核查等步骤进行了理论案例研究。分类采用总颗粒浓度和环境监测数据,建立无菌灌装生产线的常规微生物和颗粒监测点。洁净室分级为A、B、C、D级。

分类后,对所定义的监测点进行风险评估。采用FMEA等风险评估方法对点数和危险程度进行分配,然后计算各个地点的监测频率。

利用监控程序来达到当前法规要求,良好的生产规范以维持稳定运行是至关重要的。在核查最终监测计划的执行情况时,还应了解和规划新兴实践。

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