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.
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