Commissioning and Qualification of a laboratory instrument is the documented collection of activities which are delivered within the limit of expression to demonstrate its ‘fitness for purpose.’ Analytical laboratories in pharmaceutical industries are equipped with analytical instruments that range from a simple instrument having no measurement capability (e.g. analogue magnetic stirrer) to complex instruments (e.g. HPLC) associated with a computerized system. The Generation of integral, secure, reliable and consistent data necessitates the use of Qualification of Analytical instruments. The extent of qualification of an instrument depends upon its complexity and intended use. The more the complexity of instrument or the higher the criticality of measurement, the more work needs to be done to ensure data quality.
There are many ways to demonstrate the validated state of any instrument which includes qualification, validation, calibration, maintenance, re-qualification and periodic qualification. A scientific risk-based approach should be selected to carry out an Analytical Instrument Qualification (AIQ). The classification of analytical instruments and categorization of associated software utilizes risk assessment scenarios to determine the extent of qualification and actions needed to demonstrate fitness for purpose.