You may read the term Good Laboratory Practice (GLP) and assume it covers all laboratory activities, but this is not the case. 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 process of new chemicals and substances in order to understand and control their properties so they can safely be tested in, on or around humans. GLPs are intended to ensure a high caliber of data so regulatory reviews of a product for safety and efficacy in a marketing application are valid and reliable. GLP rules are required worldwide because these early steps in product development have a huge impact on public health.
This course will provide 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). It outlines the regulatory systems involved in creating and improving GLPs within the goal of human safety and medical benefit. Students will also gain an understanding of how GLPs fit into a quality system, what types of studies are covered and how GLPs for the US and internationally fit together.
Learning Objectives
Upon completion of this course, participants should be able to:
- Explain the purpose of GLPs
- Define the major GLP regulatory systems
- Describe the types of studies to be conducted under GLPs
- Explain the relationship of GLPs to an overall quality system
- List key areas of emphasis under the US Food and Drug Administration (FDA), US Environmental Protection Agency (EPA) and the Organization for Economic Cooperation and Development (OECD) for GLPs
Target Audience
This course is designed for personnel in regulatory, compliance and quality assurance; laboratory management; study directors; and technicians.