The ICH guideline on method validation, Q2 (R1) [1], is currently being updated and I thought it might be interesting to put together a wish list for the changes that I would like to see in the new version. Rather than a wide-ranging treatment of all analytical method validation related issues, such as how it […]
Category: Validation
Where do the Acceptance Criteria in Method Validation Come From?
MTS Helpdesk Webinar Recording 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(R2), don’t mention any numbers. […]