A Brief Guide to...

Where do the Acceptance Criteria in Method Validation Come From?

This video is a recording of a webinar originally presented on the 29th July 2020. An additional session was delivered on the 12th August 2020. One of the most difficult tasks when writing an analytical method validation protocol is to set suitable acceptance criteria, particularly for the characteristics of accuracy and precision. It sometimes seems that the values are just plucked out of the air! Available guidance documents, such as ICH Q2(R1), don't mention any numbers. In this webinar we looked at the relationship between inherent analytical error and validation acceptance criteria to give an understanding of where typical values come from.