HPLC chemist wrote:
Other acceptance criteria are what your method can perform.
I would contradict this. Acceptance criteria for validation must be what your method SHOULD perform, not what it CAN perform. It depends on what you want to do with this method. What are the specifications your product must fulfill?
Just as an example, if you have an assay with a specification limit of 90-110 % then a limit of 2% RSD for a 6-fold injection ist fine. If you're testing a pharmaceutical API with an assay specification of 98.5%-101.5%, then 2% RSD for 6-fold injection is way too much.
There actually are little to absolutely none "official" references for acceptance criteria (even USP 621, as quoted, only refers to USP monographs, at leat officially). Bad part: you have to define them yourself. Good part: you can define them yourself.
"State of the art" would be to define an "analytical target profile" or ATP - basically that's just a definition of what the method is supposed to do. Remember that in the end validation is NOT executing a standard validation protocol which is predefined and the same for any validation you perform - it is showing that the method is able to do what it is supposed to do. Meaning that the acceptance criteria may be different for every validation you perform...