RE: in-process control for coating tablet Contribution from Bernd Renger written on 9/11/2008 at 13:19
Original contribution: in-process control for coating tablet written by Dvid on 9/11/2008 at 03:26) According to the European GMP Guide in-process controls are “checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms its specification”. So the frequency and the types of tests to perform highly depend on the individual product’s characteristics rather than on a dictated rule.
Just perform a risk evaluation – e.g. how often do I have to perform checks to assure batch uniformity – and defend it.
Answering this Contribution:
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