ABSTRACT
Validation was initially introduced in the 1970s to the
pharmaceutical industry as a means for 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 BPCs were particu-
larly 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 recalci-
trance of this segment of the industry. This view was
widespread in the BPC industry through the end of
the 1980s.
