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A risk based approach to determine the calibration interval is recommend for all GxP applications.

 

The scientific proof would be the historical calibrations taken at different intervals, where if sequential results are stable, the periodicity can be extended.

 

The appropriate calibration interval would be defined based upon the following points:

 

Measurement accuracy:

•Measurement device drift,

•Measurement device accuracy,

•Measurement accuracy required for the application...

 

Various risks:

•Physical damage,

•Chemical damage,

•Mechanical damage,

•Environmental damage...

 

No matter what calibration interval is selected, the calibration interval is application and measurement device dependent.

 

All decisions should be based on good calibration procedures and standards. The measurement device life expectancy can be determined based upon calibration data.

 

Rotronic recommend calibrating all devices once a year.