A comparison of the U.S. EPA FIFRA GLP standards with the U.S. FDA GLP standards for nonclinical laboratory studies.
In the early 1980's both the Environmental Protection Agency and the Food and Drug Administration were receiving studies on the products that they regulate that were unscientifically sound, some even being fraudulent. Studies were being submitted that had not been done under sound scientific practice; data were missing; necessary documentation to reconstruct the study, also known as an audit trail, was not in place, it was this evidence that lead to the Good Laboratory Practice Standards (GLPs) being codified and becoming regulation. The GLPs were meant to assure that studies submitted to the agencies for the registration of products for which they were responsible would protect the environment, and, the safety and health of the public.
Keatley
K L
KL
Pyxant Labs, Inc., Colorado Springs, USA. klkeat@juno.com
D000818:Animals; D019985:Benchmarking; D004353:Drug Evaluation, Preclinical / Q000592:standards*; D004345:Drug Industry; D005161:Facility Regulation and Control / Q000458:organization & administration*; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D007753:Laboratories / Q000331:legislation & jurisprudence / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000458:organization & administration; D012042:Registries / Q000592:standards; D012107:Research Design / Q000331:legislation & jurisprudence / Q000592:standards; D014481:United States; D014484:United States Environmental Protection Agency; D014486:United States Food and Drug Administration