Good Laboratory Practice (GLP)

Good Laboratory Practice (GLP) designates a quality system governing nonclinical laboratory studies, ensuring that research data supporting regulatory submissions meet rigorous standards for planning, performance, monitoring, recording, and reporting. These international regulations establish organisational processes, personnel qualifications, facility specifications, equipment maintenance, and study conduct procedures. GLP compliance proves essential for toxicology, pharmacology, and other nonclinical safety studies submitted to regulatory agencies.

The pharmaceutical industry conducts GLP studies through internal laboratories or contract research organisations meeting regulatory requirements from FDA, EPA, OECD, and other authorities. Key GLP elements include study directors assuming responsibility for technical conduct, quality assurance units independently monitoring compliance, standard operating procedures governing laboratory operations, and personnel possessing appropriate education and training. Archives maintain study records enabling reconstruction and audit. Computer systems require validation ensuring data integrity. As nonclinical testing evolves incorporating new technologies and alternative methods reducing animal use, GLP frameworks adapt while maintaining fundamental principles ensuring data quality and regulatory acceptability.