Recent changes in FDA's good laboratory practice regulations

Abstract

In the Federal Register of December 22, 1978, the Food and Drug Administration (FDA) published regulations which described Good Laboratory Practice for safety tests conducted on regulated products (Anonymous, 1978). The regulations, popularly known as GLPs, have become universally recognized as the basic criteria for the conduct of a valid safety test and for assuring the quality and integrity of the collected data. Along with the publication of the GLPs, FDA instituted a vigorous program of inspection of toxicology laboratories to determine the degree of adherence to the regulations. In 1984, based on inspectional findings which revealed that a large majority of toxicology laboratories were adhering to the GLPs, FDA published a proposal intended to reduce the burden of compliance with the regulations (Anonymous, 1984). The proposal outlined major changes in the provisions on quality assurance, protocol preparation, test and control article characterization, and retention of specimens and samples. The final order based on the proposal was published in the federal register of September 4, 1987 (Anonymous). The purpose of this communication is to describe the procedures used by FDA to develop the final order, to discuss certain major issues that arose during its development, and to answer several questions that have arisen subsequently.

Keywords:

• quality assurance
• safety studies
• good laboratory practice