We validate our HPLC and other test methods at R&D using cGMP guidelines, and use technology transfer validation studies for our QC laboratories in different states. Our QA just sprung on us that they want our QC laboratories to also validate the same test methodologies at their sites; these test methodologies have been used for years, and test method transfer validations were easily completed. Anybody hear of cGMP repeating/doing test methodology validations for each satellite location, or does our QA guy have it wrong? We have all our instruments undergo yearly performance verifications, etc.

No way you need to re-validate if you do a proper initial validation and a proper test method transfer. It sounds like you are doing everything right and your QA guy does have it all wrong.

I agree with Scott, I think you need to show precision (repeatability, intermediate) only provided you show accuracy, precision, specificity, robustness, etc at the R&D site. I can remember in the past we would re-validating at different sites. It is the think of the past.

"It is the think of the past" - I like this sentence. Gotta right it down...

Yes, all you should have to do is a method transfer or method verification depending on whether or not the test is compendial.

You have to perform the precision, system suitability and a demostration of LOD can be a part of method transfer.