GLP Compliance: A Rededication to Effective Quality Assurance

Effective quality assurance serves not only to promote the timely delivery of a final product that conforms to predetermined quality standards but also to assure that the entire work process comports with established regulatory requirements. The Food and Drug Administration (FDA) published good laboratory practice regulations that became effective on June 20, 1979. The regulations were intended to assure the quality and integrity of the safety data submitted to FDA for regulatory decision making. There is no question that the regulations have had a beneficial effect on the quality of toxicology testing. In general, FDA continues to receive final reports of unquestionable quality. However, more efforts must be directed to gain full compliance to regulatory requirements. These efforts should include an intensification of the role of management in the process and of the role of the quality assurance unit in monitoring the work process. The time has come for a rededication to the principles of effective quality assurance.