Trends in Analytical Instrument Qualification

C ompanies are increasingly using outsourced multivendor qualification services for analytical instrumentation (1). This trend and the advantages of such an approach over other available options can be explained by some historical scene setting, along with descriptions of some of the main qualification approaches available. Like many other industries, the pharmaceutical industry is highly regulated. It has to be: Tight regulation protects lives. The Food and Drug Administration (FDA) is a global force in this tight regulation through the actions of field-based inspections and through the regulatory guidelines it issues. Typically, approaches introduced by the FDA are adopted by other regulatory bodies and other industries. Therefore, although analytical instrument qualification largely originated in the pharmaceutical industry, the principles and valueadded activity are universally applicable to other industries.