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OOS and Cleaning Validation

Posted: Tue Jun 15, 2021 1:50 pm
by etaxene
Hello everybody. Are there guidelines for the management of the OOS during the Cleaning Validation phases?
I don’t know how to handle them. Whether as a laboratory OOS or process deviations.

Thanks!

Re: OOS and Cleaning Validation

Posted: Thu Jun 17, 2021 6:26 am
by epsilon
I use 3M method (man-material-machine) or an extended fishbone analysis :)