This section explains how qualified analytical instruments are maintained in a state of control throughout routine operation. It covers calibration, performance verification, preventive maintenance, repairs, change control, performance trending, periodic review, requalification, return to service, and instrument retirement.
Calibration and routine performance verification provide evidence that analytical instruments continue to measure and operate within defined requirements. They are related to instrument qualification, system suitability, maintenance, and adjustment, but they do not serve the same purpose. A defensible calibration…
Preventive maintenance preserves analytical instrument function before failure occurs. It may include inspection, cleaning, lubrication, replacement of wear components, leak testing, alignment, diagnostic testing, software-supported service activities, and other work recommended by the manufacturer or justified through operating experience. Maintenance…
Analytical instrument repair begins with containment of the failure, not with replacement of the defective part. Before intervention changes the instrument’s condition, the laboratory should preserve available evidence, remove the affected system from GMP use, identify the failed function, and…
Analytical instrument periodic review and requalification are related but distinct lifecycle controls. A periodic review is an evidence-based assessment of whether an instrument remains suitable, controlled, supported, and compliant. It consolidates information generated during routine operation and determines whether current…