OOS average Contribution from Wamba written on 2/1/2012 at 18:54
Let us say that an assay method requires 20 tablets of a batch should be crushed in a mortar. Of the powder mixture is then three samples prepared by weighing. The samples are analyzed by HPLC and three results are obtained. The average of these results is within specification but one of the results is not within specification. The variability between the values are small. Is it OK to use the average result and approve the batch? Answers to this contribution:
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