Which parameters shall be used for verification of compendial method?

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

I am preparing an SOP on the topic Validation and Verification of analytical method, if you can explain which parameters shall be used in case of verification of compendial method then it would be great help for me.

I have referred ICH Q2(R1) guideline and USP chapter <1226> also.

Thank you
Manojkumar

2

It’s in USP <1226>. Usually, this includes specificity, linearity (including LOQ), accuracy, precession…
The acceptance criteria is the same as your specifications.

3

Hi,

Method verification is to determine method suitabilityunder the actual conditions of use. Therefore I tend to evaluate each method for potential risks given local laboratory conditions (quality of reagents, equipment available, supplies, analyst training, experience with similar methods, etc.). By default I consider the parameters recommended in the original proposal for USP 1226 according to Pharmacopeial Forum 31(2) and expand from there on a case-by-case basis.

Once the parameters are chosen, acceptance criteria requirements should be aligned with those used to validate such parameters.