ABSTRACT
I. HISTORY Validation was initially introduced in the 1970s to the pharmaceutical industry as a means of more firmly establishing the sterility of drug products where normal analytical methods are wholly inadequate for that purpose. In following years, its application was extended to numerous other aspects of pharmaceutical operations: water systems, environmental control, tablet and capsule formulations, analytical methods, and computerized systems. Individuals working with bulk pharmaceutical chemicals (BPCs) were particularly reluctant to embrace validation as a necessary practice in their operations. Industry apologists explained this lack of enthusiasm in terms of differences in facilities, equipment, technology, hygienic requirements, cleaning methodologies, operational practice, and numerous other aspects of disparity that seemingly justified the recalcitrance of this segment of the industry. This view was widespread in the bulk chemical industry through the end of the 1980s.
