Good Laboratory Practice
Good Laboratory Practice (GLP) is a quality system framework that ensures the reliability, integrity, and traceability of non-clinical safety data generated during laboratory studies, particularly in pharmaceuticals, chemicals, and agrochemicals. It provides standardized procedures for planning, performing, monitoring, recording, reporting, and archiving studies to support regulatory submissions. GLP is enforced by regulatory agencies like the FDA and OECD to maintain data quality and protect public health.
Developers should learn GLP when working in regulated industries such as pharmaceuticals, biotechnology, or environmental testing, where software systems manage laboratory data for regulatory compliance. It is essential for ensuring that electronic data capture (EDC), laboratory information management systems (LIMS), and other lab software meet audit requirements and produce valid, reproducible results. Knowledge of GLP helps in designing systems with features like audit trails, data integrity checks, and proper documentation to avoid regulatory penalties.