Equipment Calibration and Qualification

Analytical practitioners place great faith in the readings and outputs from their instruments. When unexpected or out of specification results occur, the initial suspicion often falls on the sample, the preparation technique or the analytical standard employed. Rarely is the equipment questioned. Indeed, the whole underpinning of method validation assumes that the analytical equipment used to acquire the experimental data is operating correctly and reliably. 

Some industries that are highly regulated, such as the pharmaceutical sector, have placed great emphasis on method validation in, for example, HPLC. However, until recently, there has been little direct requirement for assuring that the analytical instruments are working properly. 

In contrast, the ISO Guide 25 approach (updated in 1999 to ISO Guide 17025), as expanded in ref. 14 heavily focuses on good analytical practices and adequate calibration of instruments with nationally or internationally traceable standards wherever possible. 

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