ABSTRACT
Good laboratory practice (GLP) standards were initially described in the late 1970s as a set of rules to provide stringent regulatory requirements for research testing of products that fall under the guidance of the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA). In 1989, the rules were codified by EPA as 40 CFR parts 160 and 792 for FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act) and TCSA (Toxic Substances Control Act) and by FDA in 21 CFR part 58. Currently, these GLP standards
differ only to the extent necessary to reflect the agencies’ different statutory responsibilities. The standards address nonclinical or preclinical studies in laboratories that perform chemical, animal, or field studies in support of applications for research or marketing permits. Compliance has been monitored through a program of laboratory inspections and data audits coordinated between EPA and FDA, with FDA carrying out inspections at laboratories that conduct health effects testing and EPA inspecting laboratories that conduct health effects, chemical characterization, and environmental fate studies. Good laboratory practice standards have also been established in over 31 countries across the world, making these standards a universal language of quality assurance (QA).
