Hello, colleagues!

There is commenting open for new upcoming edition of USP 1033. Validation target acceptance criteria is now different from what it used to be and it doesn't include Cpm. Probability of OOS is now calculted on the basis of manufacturing mean and production process variability. I have difficulties understanding the source from which one determines values of RB and IP for required calculation of Prob(OOS) through steps, described in USP. Are these values gathered from randomly selected lots? Are these lots different since we have two different RB and IP values (15 and 12 for RB, 20 and 18 for IP)?

More Sergey Smirnov's questions See All
Similar questions and discussions