hi everyone , hope you are doing well
i have a question about acceptance criteria
is it preferable to mention acceptance criteria after each test is our SOP?
is there any mandatory guide about this in guidelines ? whether for mentioning or not mentioning acceptance criteria in our analytic SOPs
You may not mention acceptance criteria after each test in the SOP. You can provide reference to the Acceptance criteria for those tests such as for Raw material, Intermediate, Packaging material, Final product specifications, OR Qualification -IQ, OQ, PQ and Validation protocols, etc. where Acceptance criteria are always defined.
However, if there are no separate specification or acceptance criteria defined elsewhere, then you can mention acceptance criteria in the SOP, such as Calibration acceptance criteria, Action & alert limits, etc.
This topic was automatically closed 10 days after the last reply. New replies are no longer allowed.