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.
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.
Our projects with NorthEast BioLab include method development, stability studies, cross-validation of other labs, support for investigator-sponsored studies, and Clinical Phase I – IV studies. They have considerably exceeded our expectations time and again.
NorthEast BioLab provided critical insight into data analysis, and are compliant with industry best practices and regulatory standards. We would certainly recommend them and look forward to working together in the future.
NorthEast Biolab truly goes that extra mile to make the collaboration successful, and I will continue to enjoy very productive interactions with them in the future. The integrity of the staff is as refreshing as their willingness to provide ingenious scientific input and high-quality data.
Our latest study together was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers needed swift analysis. This study, same as all other bioanalytical studies with NorthEast BioLab, was completed with very high quality and reporting standard and incredible responsiveness.
NorthEast Biolab is by far the most responsive and thorough bioanalysis service provider. They work closely with the client to provide the most efficient and cost-effective approach to get the job done.
We have worked with NorthEast Biolab on several programs and have found them to be professional, collaborative, and responsive. As a small company, our vendors are key members of our project teams. The scientists at NorthEast Biolab are technical experts, who produce high-quality data, on-time, and on-budget.
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.
The assay testing list below illustrates the extensive GLP lab capabilities of NorthEast BioLab:
Bioanalysis is an essential tool in drug discovery and development for determining the concentration of drugs and their metabolites as well as various pharmacodynamics biomarkers in biological fluids. In these analyses, scientists use developed an….
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.
