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RE: in-process control for coating tablet

Contribution from Roy Cowell written on 9/11/2008 at 13:32

Original contribution: in-process control for coating tablet written by Dvid on 9/11/2008 at 03:26)

I am unaware of any specific guidelines relating to the frequency of in-process controls. You should look to your process validation data and make a risk based assessment of the frequency of testing required. This should be documented as prescribed by your quality management system. Regular review of your in-process data would then direct you to increase or decrease the frequency of testing as necessary (with appropriate change control) and directed by uncertainty in your process.

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