ABSTRACT
The Food and Drug Administration (FDA) describes the biopharmaceutical industries as “self regulated,” retaining for itself the responsibility of assuring and checking on that self-regulatory process. Not surprising, then, the FDA energy is expended in areas based not upon their absolute importance, but upon the lack of industry capability of controlling a particular concern. When manufacturing processes were primitive, unclean, and uncontrolled, the FDA issued the “good manufacturing practices” (and, eventually, the good laboratory practices, good clinical practices, and good tissue practices) to provide standards for the industry operations.
