Bioequivalence and Bioavailability Forum

Dear Ramesh,

The OECD GLP guideline states (§4.2) that Apparatus used in a study should be periodically inspected, cleaned, maintained, and calibrated according to Standard Operating Procedures. Records of these activities should be maintained. Calibration should, where appropriate, be traceable to national or international standards of measurement.

There is no specific guideline giving a minimum periodicity. This will be user-defined, based on manufacturer recommendations, use of the equipment, and previous experience.

In the specific case you are giving (solvent dispenser) a lack of precision or accuracy in the volume delivered would have no impact if you have an internal standard. But checking the pipette used to distribute the plasma samples or the IS would be much more critical.

GLP section 4.2 applies to any kind of equipment used in your study, from the freezer used to store your plasma samples to your HPLC system.

Regards
Ohlbe