Good Laboratory Practice (GLP) study: Quality Assurance and Control Standards by the FDA
GLP, commonly utilized in nonclinical or preclinical research studies, is a quality control system for management of research and development laboratory methods. Good Laboratory Practices by the FDA ensure high consistency, uniformity, reproducibility, reliability, integrity, and quality in nonclinical safety tests, toxicity tests, and physiochemical property studies.
In the preclinical research and development, GLP labs assess the safety profile, therapeutic dose, and chemical efficacy of the drug being tested on animal models. Note that Good laboratory practices should not be mistaken with necessary laboratory safety during nonclinical studies such as effective utilization of appropriate personal protective equipment (PPE). Instead, good laboratory practices provide guidelines such that the studies are conducted under proper conditions, documented correctly, and provide reliable results.
As GLP lab, a facility must have (a) sufficient scientific staff with specific responsibilities, (b) an independent Quality assurance unit, (c) appropriate test facility to perform all research (d) all necessary equipment that is well maintained and calibrated, and (e) comprehensive SOPs to cover all operations. Studies must be performed under a defined study plan, and all documents related to studies must be archived and saved for at least 20 years.