This presentation provides information to the quality assurance professional that will enable him or her to conduct GLP audits/inspections in an academic environment that are efficient and constructive. This includes information about academic self-perceptions, academic organizational structure, academic organizational practices, and academic research formats. GLP audits/inspections conducted in academic toxicology laboratories are not merely inconveniences to be tolerated, but useful tools, especially if the GLP auditor/inspector is used as an educator and resource.
References
1.
1. Dewoskin, R., and Taulbee, M. (1988). Quality Assurance in an Academic Laboratory. Presented at the 1988 Annual Meeting of the Society of Quality Assurance, October 20, 1988, Nashville, Tennessee.
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2. U.S. Food and Drug Administration. Good Laboratory Practice Regulations; Final Rule, 21 Cfr Part 58. U.S. Environmental Protection Agency. Toxic Substances Control Act (Tsca); Good Laboratory Practice Standards; Final Rule, 40 Cfr Part 792. U.S. Environmental Protection Agency, Federal Insecticide, Fungicide and Rodenticide Act (Fifra); Good Laboratory Practice Standards; Final Rule, 40 Cfr Part 160.
3.
3. Wheeler W., and Thompson, N. (1988). Good laboratory practice standards in a university setting. In: Garner, W. Y. and Barge, M. S., eds. Good Laboratory Practices: An Agrochemical Perspective. Acs Symposium Series 369. Washington, D.C.: American Chemical Society, p. 127.
4.
4. Good Laboratory Practices: An Agrochemical Perspective., p. 128.
5.
5. Spittler, T. (1988). University responses to good laboratory practices: case history. In: Gamer, W.Y. and Barge, M.S., eds.) Good Laboratory Practices: An Agrochemical perspective. Acs Symposium Series 369. Washington, Dc: American Chemical Society, p. 118.
