What is Good Laboratory Practice (GLP)?

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.

Role of Good Laboratory Practices during Drug Discovery and Development

Due to the immense significance of drug tests and analyses findings, it is essential that the FDA look closely and audit frequently before the generated data helps push through drug approvals. Thus, it is crucial that labs follow predetermined rules and regulations to ensure the validity, integrity, and reliability of nonclinical and clinical data. Good laboratory practices allow laboratories to use their data and to make the most of what they are doing about their current studies and experiments. Following good laboratory practices is critical and can make a world of difference in how your study gets approved, whether they pass their inspections and whether their findings are accepted.

NorthEast BioLab follows FDA and OECD principles during preclinical toxicity studies that are carried out as part of IND packages. The FDA and OECD provide guidelines for the evaluation of safety and toxicity of the drug in various animal species. Even as GLP labs are not needed for clinical studies, we follow similar principles in clinical testing to ensure that reliable and robust results are generated.

Following studies illustrate the extent of GLP lab capabilities of NorthEast BioLab:

• Method Development and Validation
• Liquid Chromatography-Mass Spectrometry
• Clinical Pharmacokinetics (PK) Study
• Toxicokinetics (TK) Study
• Bioequivalence and Bioavailability Studies

Why choose NorthEast BioLab for your Good Laboratory Practice Services?

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.