Qualify or Calibrate? is it necessary to qualify (IQ/OQ/PQ) balances, scales, PH meters, etc. all equipment that is calibrated with certificates?

Please have in mind that for equipment qualification also risk assessment /risk analysis should be applied. As a consequence it may be possible to reduce qualification work a lot.

Also within the guidelines it is mentioned that sometimes it is not possible to clearly distinguish between IQ and OQ e OQ and PQ and therefore can be covered by one qualification plan or report.

Therefore I would recommend that your SOP for equipment qualification includes a regulation for some specified instruments that it is possible to perform IQ and OQ together and PQ may be substituted by calibration and/or adjustment in regular intervals or before use.

Herbert Syrowatka Quality Systems Consulting GmbH