Frequency of Instrument Calibration

[ajrapport]

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!

[KM-USA]

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

[tom jupille]

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.

[Gerhard Kratz]

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

[KM-USA]

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.

[Alfred88]

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.