Auditing metabolism studies: a scientist's perspective.

Abstract

Metabolism studies conducted for submission to regulatory agencies are notorious for presenting difficulties during QA audit. The problems result from many factors, most of which stem from the research nature of such studies. Monsanto-Ceregen's Environmental Science Department (ESD) management has organized a concerted effort to review and change the way our regulatory studies are conducted, especially metabolism studies, with the objective of making the work less expensive in time and money, yet more GLP compliant. The strategy employed toward this objective, which requires that the changes be both developed and implemented by study workers (as opposed to QA workers), is discussed. Examples are given of measures implemented thus far that affect the efficiency and GLP compliance with which our metabolism studies are conducted and audited. These measures fall in two categories: (i) excellent SOPs and (ii) techniques that permit efficient auditing of metabolism study Final Reports.