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.

References

1. FDA. (1987). Nonclinical laboratory studies—Good laboratory practice regulations. Fed. Register 52, (172), 33768–33782.

2. Deming, W.E. (1986). Out of the Crisis. Cambridge, MA: Massachusetts Institute of Technology, Center for Advanced Engineering Study, pp. 18–96.

3. Walton, M. (1986). The Deming Management Method. New York: The Putnam Publishing Group.

4. Harrington, H.J. (1987). The Improvement Process, How America's Leading Companies Improve Quality. Milwaukee, WI: Quality Press, p. 39.

5. Collins, F.C. (1987). Quality: The Ball in Your Court. Milwaukee, WI: Quality Press, p. 82.

6. Scherkenbach, W.W. (1988). The Deming Route to Quality and Productivity, Road Maps and Roadblocks. Rockville, MD: Mercury Press, pp. 35–40.

7. Karatsu, H. (1988). TQC Wisdom of Japan, Managing for Total Quality Control. Cambridge, MA: Productivity Press, p. 96.

8. Miller, M. , and Hayes, D. (1985). Poster on How to Make a Small Quality Assurance Unit Work Big. Presented at the Society of Quality Assurance Annual Meeting, October 15–18, 1985, Orlando, FL.