RE: RE: BMR Issue Contribution from GK Kalpathi written on 8/31/2010 at 17:53
Original contribution: RE: BMR Issue written by Vinayak V. Haldankar on 8/31/2010 at 12:13) Not just WHO Guideline, but 21 CFR 211 also requires that Quality Unit (QU) is responsible for control of documents besides other responsibilities.
The logic is - BMR is a very important document giving the full history of the batch. Moreover, the batch can not be released with out the QU review for completeness and deviations, if any. By issuing the BMR and receiving it back after the batch completion ensures document control and timely review. Answers to this contribution:
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