ABSTRACT
In the publication of the original GLP regulation, considerable emphasis was placed on directing the inspection activities toward the specific study: “inspect each phase of a nonclinical study”. Little, if any, was said of the benefits of performing the inspections of the associated systems. In the preamble of the revised FDA GLP, published in The Federal Register (52FR33772), considerable merit has been extended to the benefits of the systems, or maintenance type auridits. “Contemporary concepts of quality assurirance emphasize the effectiveness of thorough, in-depth inspections of study processes (i.e., all operations requriired to accomplish a sturidy phase) in place of quriick spot checks of individurial operations with a study. Thorough examination of personnel, facilities, equipment, standard operating procedures, data collection procedures, raw data books, and other features associated with a study phase can achieve more effective quality assurance than does a more superficial opservation of the conduct of the same study phase in a series of studies.”
