TRENDS IN ANALYTICAL INSTRUMENT QUALIFICATION

Like many industries, the pharmaceutical industry is highly regulated. It has to be: regulation saves lives. The Food and Drug Administration (FDA) is a global force in this arena through its field-based inspections and guidelines, and its approaches are frequently adopted by other regulatory bodies. Despite largely originating in the pharmaceutical industry, the principles and value-added activities of analytical instrument qualification are universally applicable. Here we use some historical scene setting to explain the trends and advantages of such an approach.