Good Laboratory Practice, GLP Studies, GLP Lab

GLP Laboratory

Good Laboratory Practices (GLP) are put in place to enhance the overall quality management system for preclinical studies as per regulatory guidelines. In GLP studies, we thoughtfully amend assay analysis and quality assurance roles as well as assign additional accountability for Standard Operating Procedure (SOP) conformity and lab management. US FDA expects all GLP labs to provide a suitable quality framework for reliable drug development data to make informed regulatory decisions. NorthEast BioLab offers customized GLP studies with exceptional attention to strong data integrity for your drug development and approval.

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.

GLP/GCLP compliant, FDA audited, and DEA & CT State Schedule II-IV approved lab

When Good Laboratory Practices are essential, NorthEast BioLab takes care to ensure that sample analysis for all your studies is conducted in full compliance with current standards set forth by the FDA and OECD. Moreover, our labs are entirely GLP compliant which helps in successful audits by regulatory authorities for such studies.

Owing to our strict compliance adherence and experienced management, NorthEast BioLab has a spotless audit record from various agency and client inspections. To the end, we also ensure that all our employees follow safe FDA, GLP, GCP, EPA, CDC, OSHA, and HIPAA regulations during drug discovery and development.

Finally, practitioners often misunderstand and understate the importance of proper bioanalytical testing. As GLP lab, each facility is held to uniform standards and required to follow criteria set forth by the FDA during drug testing and clinical trials. Our thorough understanding of GLP comes from accurate bioanalysis and running a fully GLP compliant bioanalytical laboratory for 15+ years.