Facts to Know About Good Laboratory Practices (GLPs)

Facts to Know About Good Laboratory Practices

Good laboratory practices (GLPs) are a set of principles that provides a framework to ensure the uniformity, consistency, reliability, reproducibility, and quality of nonclinical safety tests. This set of principles is utilized to 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.

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.

Good Laboratory Practice, commonly utilized in nonclinical or preclinical research studies, is a quality control system for management of research and development laboratory methods. GLP labs assess the safety profile, therapeutic dose, and chemical efficacy of the drug being tested on animal models.

We at NorthEast BioLab understand that FDA approval process is a massive undertaking and selecting the right partners, who prioritize in sync with you and focus on high quality and fast turnaround, goes a long way in avoiding missteps and moving your drug program closer to success.Did you know that the process of bringing a drug to market takes about 15 years? Breaking it down further, approval of a new drug is a massive undertaking and selecting the right partners, who prioritize in sync with you and focus on high quality and fast turnaround, goes a long way in avoiding missteps and moving your drug program closer to success.

Clinical drug development is a massive undertaking! Choosing the right partner for your drug program will help you avoid missteps, focus on high-quality work, and move your drug program closer to success. Below, NorthEast BioLab attempts to put together a quick version of the FDA and U.S. government’s step-by-step process for new drug approval. 

NorthEast BioLab is a full-service drug development company offering drug development capabilities spanning preclinical through commercial stages. Our team consists of accomplished professionals who have been working in the industry for more than 20 years and have worked with leading Pharmaceutical, Biotechnology, and Medical Device clients.

In most cases, a new drug goes through a multiphase clinical process that can take up to 15 years before it’s approved by the Food and Drug Administration (FDA). Roughly 90 percent of drugs that enter clinical phases never make it to market. The FDA drug approval process is extremely complex and difficult, given the number of checks and balances that are built into the system for protection of human health. The process may at times appear slow and cumbersome. But, it is this process that ensures that every approved drug offers a remarkable benefit when compared to the known side effects.

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