Chromatography Forum

Hello - is there any specific (USP/ICH) guidance stipulating the frequency with which instruments need to be calibrated (i.e., bi-annually, annually)? Thank-you in advance for your response!

We do OTC pharmaceuticals under cGMP. Our SOP states once per year. So that's what we do.

To be nit-picky, an instrument should be *calibrated* daily for each method that will be run. "Performance Qualification" (which is what I think you're referring to) is typically done annually (in conjunction with regular preventive maintenance) and whenever maintenance / service / repair has been done on the instrument. The idea is to verify that it's operating properly before it is put back into service.

I agree with Tom, so I did after repair of the pump or injection system.

We do OTC pharmaceuticals under cGMP. Our SOP states once per year. So that's what we do.

I need to add that all cGMP or GLP assays have full system suitability runs bracketing samples as well.

We use the term "verification" instead of "calibration" for complex instrument like HPLC.
For the frequency, some firms perform the verification two times a year, while others do it once a year. This is "industry practice," and it is not defined in a guidance document.