Hi folks,
I’m seeking a justification for retrospectively carrying out test method validation after design verification testing.
i.e. Testing to method that are not yet validated.
Can anybody help?
Boy you are in LUCK! You can do a historical revue and then demonstrate compliance with the ‘new’ ICH Q2(r2) guideline. However, all the facets covered by this protocol (linearity, specificity, robustness…) will be acceptance criteria of ICH Q2(r1) as well as ‘stability of solutions’.