Who Are the Players, and What Do They Bring to the Science and Compliance Teams?

Abstract

The aim of a Good Laboratory Practice (GLP) toxicology study is to provide useful information on the toxicity of a compound to a multiplicity of internal and external groups. Using the principles of total quality management (TQM), a multidisciplinary team is formed to plan the strategy for either an improvement or a change in a GLP toxicology study. The team members use their respective expertise to clarify their expectations and jointly define a common goal. Through carrying out the planned improvement or change, assessing the results, and replanning a GLP toxicology study, the stage is set for a continual improvement process. At the heart of the process is the willingness of team members to openly communicate and work together toward a common goal. The end result of using a dynamic TQM approach is that a GLP toxicology setting can result in continual improvements, better study planning, and a decrease in defects. Science and GLP compliance become members of the same team and a winning combination for successful management of GLP toxicology studies.