Building a quality assurance system into a GLP laboratory

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.