THE FDA’S GLP OUTLOOK DOCKET

Abstract

The GLP (Good Laboratory Practice) inspection procedures and the statistical evaluation of the complete inspections, one must still ask “How have the GLP inspections impacted new drug evaluation?”. First, the people responsible for FDA’s (Food and Drug Administration) bioresearch monitoring program are encouraged by the results of the GLP inspection seen in terms of industry’s growing acceptance of the GLPs as a means of establishing a level of reliability for scientific testing. Furthermore, it is know that the deficiencies found by our inspection in the past year are not as severe as in recent years and the cooperation we are now receiving from laboratories during the investigations is at a higher level. Finally, and most important, the pharmacologists at the agency, particularly those who are keenly aware of the conditions that existed before the GLP regulations came into effect, are in agreement that the GLPs have made the reviewer’s tasks much easier, and they, the reviewers, feel more confident of the reliability of the information that comes   across their desks.