Good Laboratory Practice (GLP) is a quality system that governs the planning, performance, monitoring, recording, and reporting of nonclinical laboratory studies.
GLP primarily applies to toxicology and safety studies used to support regulatory filings and justify initiation of human exposure. These data inform first-in-human dosing, safety margins, and monitoring plans used in early clinical protocols. Reliable GLP study conduct strengthens confidence in nonclinical findings and supports defensible risk assessments. Consistent GLP documentation helps ensure nonclinical evidence is reproducible and acceptable for regulatory review.