Analytical Instrument Qualification

Analytical instrument qualification is elaborate and demanding. Analytical instruments and devices are essential for manufacturing and quality control of biopharmaceuticals.

Most of these instruments link metrological and software-controlled functions. QA is responsible for assuring that their instruments are suitably qualified.

A risk-based approach belongs to one of the most critical GMP requirements to identify detailed instrument operating parameters to be qualified. This approach also defines the instrument classification to determine the extent of qualification activities.