RE: Working Standard Contribution from Ganesh Bugde written on 8/31/2010 at 12:35
Original contribution: Working Standard written by ch.bharath reddy on 8/30/2010 at 09:59) It is not a good advice to keep reprocess batch as working standard which will give number of questions to compliance, but if there is no alternative you can keep it as WS, provided the complete characterisation of the WS is done and in addition critical tests like assay and Related substances in triplicate to provide the data for justification. Here the values obtained of reprocess batch should be well within acceptance criteria and should not be out of trend.
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