Good Laboratory Practice (GLP)

Good Laboratory Practices (GLPs) are the minimum standards used for benchmarking proper conduct of animal safety studies in a nonclinical environment applying both in vivo and in vitro testing. They contain principles for managing and operating nonclinical laboratory testing facilities involved in the early development of new chemicals and substances, human and animal drugs, medical devices for human use, biologics, and similar products, that may possess pharmacological activity or have an impact on living organisms’ physiology or the environment. GLPs provide a framework for understanding and controlling those substances’ properties so they can be safely tested in, on, or around humans (directly or indirectly) to ensure a high-caliber of data demonstrating quality and integrity for the purpose of regulatory submissions and reviews. GLPs primarily ensure the safety, validity, and reliability of a tested product’s data results before they are submitted in a marketing application to a regulatory agency. GLP standard rules are required worldwide because these are the early steps in product development and could have a huge impact on public health. Not all early pharmaceutical testing is done under GLP standards, however. GLPs apply to animal studies typically performed prior to human studies. It should be noted that GLP rules ensure that animal studies are conducted to minimum standards set forth as a benchmark and international guidelines. In some cases, GLP standards could be more stringent than Good Manufacturing Practice (GMP) standards and, in such cases, may require a study director.
 

This course provides an overview of GLP regulations as they are applied and interpreted by the US Food and Drug Administration (FDA), US Environmental Protection Agency (EPA) and the Organization for Economic Cooperation and Development (OECD). This course outlines the role of regulatory bodies involved in creating and improving GLPs, and all sharing the goal of achieving safety standards for human use. Students will gain an understanding of how GLPs fit into a quality system, what types of studies are covered, and how GLPs align for regulatory approval processes for the US and international markets.