Good Laboratory Practices (GLPs) are the minimum standards for the proper conduct of safety testing in a nonclinical environment. They contain principles for managing and operating laboratory testing facilities involved in the early development of new chemicals and substances that may possess pharmacological activity, or may have an impact on living organisms’ physiology. GLPs intend to understand and control those substances’ properties so they can safely be tested in, on or around humans to ensure a high caliber of data for the purpose of regulatory reviews. GLP primarily demonstrates safety, validity and reliability of a product’s test data obtained before they are submitted in a marketing application to a regulatory agency. GLP rules are required worldwide because these early steps in product development have a huge impact on public health.
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). The course outlines the role of regulatory bodies involved in creating and improving GLPs with the goal of achieving human safety. Students will also gain an understanding of how GLPs fit into a quality system, what types of studies are covered and how GLPs in the US and international market align.