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发表于 2016-8-8 21:27:36
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FDA清洁验证指南第4部分第6节C段：
Test Until Clean
Examine and evaluate the level of testing and the retest results since testing until clean is a concept utilized by some manufacturers. They test, resample, and retest equipment or systems until an "acceptable" residue level is attained. For the system or equipment with a validated cleaning process, this practice of resampling should not be utilized and is acceptable only in rare cases. Constant retesting and resampling can show that the cleaning process is not validated since these retests actually document the presence of unacceptable residue and contaminants from an ineffective cleaning process.
有些工厂的做法是，自清洗开始就一直重复地检测和评估多次检测结果，直到洁净为止。他们对设备和系统进行取样、检测，再取样、复测，直至得到一个“可接受”的残留水平。对于采用经过验证的清洁方法对设备或系统进行清洗时，不应采取这种重复取样的做法。这种做法只有在极少数情况下可以接受。不断地检测和取样只能说明，所采用的清洁方法没有得到验证。因为不断的复测实际上反映并记录了这样一个事实，即进行低效的清洗之后，仍有超量的残留物/污染物存在。
APIC清洁验证指南第十部分问题6：
Question 6: Is it acceptable for a validated cleaning procedure to be continued until the analytical results demonstrate it is clean? Advice: Regulatory authorities do not condone this practice. When the analytical result does not meet the acceptance criteria an investigation to determine the possible root cause should be performed. If needed re-training of the operators should be performed and/or adjustment of the cleaning procedure to solve the issue. 问6：是否可以重复一个经过验证的清洁操作直至分析结果显示其已清洁？ 建议：药监当局不接受这种方法。 如果检测结果不符合可接受标准，则需要进行调查，找出可能的根本原因。必要时，应对操作人员进行再次培训，和/或对清洁程序进行调整以解决问题
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发表于 2015-6-2 10:18:36
