Abstract
The first edition of the Good Laboratory Practice (GLP) regulations was prepared by the Food and Drug Administration of the USA in 1976. Thus, GLP regulations have a 20 year history and have contributed greatly to the prevention of problems. In this article, the importance of ethics and a spirit of quality for the study director is described. Cooperation between the QA and the study director in establishing and maintaining the quality assurance system is emphasized. Copyright © 1998 John Wiley & Sons, Ltd.
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