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Are there any guidelines for acceptance criteria for method validation parameters?
Thank you
Discussions about HPLC, CE, TLC, SFC, and other "liquid phase" separation techniques.
I agree with HPLCAddict wholeheartedly. Perhaps also this will help:I [HPLCAddict] don't think that there are any official guidelines out there which give definite acceptance criteria for accuracy. And this is actually good, because acceptance criteria for accuracy (and any other validation parameter) can be wildly different depending on the purpose of the respective analytical method. Regarding the +-2% you mentioned, this is quite a common criterion for validation of assay tests in the pharmaceutical field. But for related substances, things are VERY different! Just think of it: at the 0.1% level defining an acceptable range of +-2% would mean you'd have to hit the 0.098-0.102% range with your recovery - impossible! I'd say there's no pharmaceutical related substance method out there which is precise and accurate enough to distinguish between these concentrations. An actually it doesn't have to.
I've seen a lot of validations of related substances methods, and usual acceptance criteria for accuracy via recovery are 90-110% or even 80-120%, especially if you look at lower concentrations close to the LOQ.
mattmullaney wrote:
@ Consumer Products Guy,
Okay then, here's a link to ORA-LAB.5.4.5, 29 Sep 2014 (current?):
https://www.fda.gov/downloads/sciencere ... 092147.pdf
The acceptance criteria remain the same as in the 24 Feb 2009 revision. Table A5 of the AOAC reference (from 2016, Appendix F.) posted above agrees with the recovery criteria FDA specifies at the 0.1% level, and though it is not a legal document, it makes a good deal of sense.
Bosses...no comment to that other than there are too many of those and not enough leaders.
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