ABSTRACT
On June 20, 1979, the Food and Drug Administration (FDA) enacted all aspects of its Good Laboratory Practices (GLP) program. The program was instituted to ensure the quality and integrity of the safety data submitted to FDA in support of the approval of regulated products, including human and animal drugs, food additives, biologicals, radiation-emitting products and human medical devices. Moreover, these considerations include all safety data submitted to support applications for research and marketing permits. These steps were taken in response to the appalling circumstances uncovered in a limited series of inspections of laboratories that was performed during 1975. FDA found careless experimentation, improperly trained employees, unreviewed data, omitted data, improper laboratory and animal care procedures and improperly monitored contract studies, including the failure of sponsors to validate the data appearing in the final study reports. The Congress responded to this situation by allocating FDA 600 new positions and .$16 million to remedy the problems that were evident. In their final form, the GLP's represent regulations fine tuned to assure proper safety testing with a minimum of increased cost. It is hoped that these regulations will increase public confidence in FDA decision making and will help to ensure that safe products are approved for marketing.
