Qualification of analytical instruments

Equipment qualification, which demonstrates that the equipment is fit for purpose and is properly maintained and calibrated, is a prerequisite for the method validation stage, which consists of studying the method's performance in terms of certain criteria (specificity/selectivity, accuracy, precision, linearity, detection and quantification limits, application range, robustness). Subsequently, it is necessary to ensure that the system's performance is maintained during routine application of the method, using system compliance tests and/or quality control samples. In the pharmaceutical industry, compliance tests are generally reserved for chemical analyses and come under "Good Manufacturing Practice", while quality control samples are the rule in bioanalysis, which comes under "Good Laboratory Practice".

These various stages form a "quality triangle", the basis of which is equipment qualification and validation of the associated IT system (not covered here). At all stages, it is necessary to "demonstrate", i.e. to provide documented, tangible proof, by supplying records and data, and recording results in data sheets.

This article covers the essential data needed to set up equipment qualification in an analytical laboratory, which is the cornerstone of this triangle of quality.