ABSTRACT
The occurrence of deviations in pharmaceutical production and analytical testing processes has been a fact of life for as long as materials have been mixed for the purpose of producing a product having medicinal properties. It has only been over the past 40 years or so, however, that both the U.S. pharmaceutical industry and its government regulators have heightened their interest in the accuracy and consistency of production and analytical techniques and technologies used to manufacture and test a drug product, biological product, or medical device prior to its distribution to the public.
