Good Laboratory Practices (GLPs) and Good Clinical Practices (GCPs): Beneficial Impact on Safety Testing

Abstract

Introduction A discussion of good laboratory and clinical practices could take the form of an objective analysis for the purpose of evaluating the impact of these practices—beneficial or otherwise—on safety testing. On the other hand, a discussion could take a biased position that such practices were either beneficial or nonbeneficial to safety testing with arguments mustered to support the favored viewpoint. With these options in mind, the topic of GLPs and GCPs are discussed from the viewpoint that these practices benefited the safety testing of drugs and chemicals to the extent that such tests are currently done in a more open atmosphere of assurance, confidence, and trust than existed in the pre-GLP/GCP era. Credit for this improved attitude must be given to the successful interplay of the implementation of good laboratory (GLP) and clinical (GCPs) practices with (a) the improved scientific status of the disciplines of toxicology and clinical pharmacology, and (b) the caliber and dedication of the men and women who practice these scientific disciplines. Of these factors, the FDA GLPs and GCPs have been of particular importance because they focused the attention of the scientific community on the fundamental procedures of record keeping and organizational systems to be used in good scientific safety experimentation