1.7.1 What is GLP?

Good Laboratory Practice is a formal quality-management system governing the organisational process and conditions under which non-clinical health and...

Good Laboratory Practice is a formal quality-management system governing the organisational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. Its purpose is to ensure the reliability, integrity, traceability, and reproducibility of study data submitted to regulatory authorities.

GLP compliance is mandatory for regulatory toxicology studies — acute, sub-acute, and chronic toxicity; genotoxicity; reproductive toxicity; carcinogenicity; and safety pharmacology studies intended for submission. It is not mandatory for exploratory pharmacological screening, mechanistic academic research, or most publication-oriented studies, although GLP-like discipline (accurate raw-data recording, defined SOPs) is strongly recommended even in academic settings as good scientific practice.