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I would really appreciate if you could let me know your opinion on the following.
Usually in LBAs, the accuracy precision batches consists of QCs( LLOQ, Low, mid and High) loaded at multiple places in duplicate. Is it must for each of the sets to pass individually or passing the grand mean is acceptable. Sometimes we find one/two replicate is not passing but the grand mean of all the replicates meet acceptance criteria of 80-120%. Will the batches with one replicate failing be acceptable for validation?
Also, do you follow the 4-6-30 rule during LBA validation,... I mean, one replicate can fail but no two replicates of the same QC level can fail?
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Would you accept a result where two of the components fail but the mean passes? Suppose you had four tires and three had severe wear but the fourth was new and unworn. Would you average the tread depth across all four tires?
The guidance describes it this way but it needs to be revised. It is the number of samples meeting the criteria not the mean of the group.
The 4/6 % rule is followed not only for plate acceptance but also for acceptance of individual validation samples used to test accuracy, precision, stability, etc.
THere are samples and replicate samples be sure to clearly differentiate. For example in accuracy and precision LBA runs there are usually six samples at each level, plated in duplicate (replicates).
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