Online CourseOnline Course Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective

Good Laboratory Practice (GLP) [3.0 RAC]

3.0 RAC Credits Member: $365.00 Nonmember: $500.00
Good Laboratory Practice (GLP) [3.0 RAC]
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 have an impact on living organisms’ physiology or the environment. GLPs provide a framework for understanding and controlling 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. GLPs primarily ensure the safety, validity and reliability of a product’s test data 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. Not all early pharmaceutical testing is done under GLP standards. However, GLPs apply to animal studies that are typically performed prior to human studies. It should be noted that GLP rules ensure that animal studies are done to minimum standards. In some cases, GLP standards can be more stringent than Good Manufacturing Practice (GMP) standards (such as the need for 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, all sharing 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 markets align.

At a Glance
  • Target Audience: This course is designed for personnel in regulatory, compliance and quality assurance; laboratory management; study directors; and technicians.
  • Learning Level: Basic
  • Total Length of Course: 3 Hours
  • RAC Points: 3

Learning Objectives

Upon completion of this course, participants should be able to:
  • Explain the purpose of GLPs
  • Define the roles of major regulatory bodies in GLP
  • Describe the types of studies to be conducted under GLPs
  • Explain the overall function of the GLP system and its integration into product safety testing
  • List key GLP areas of emphasis under FDA, EPA and OECD

Lesson Titles
  • Lesson 1: Background Overview of GLPs
  • Lesson 2: Overview of US FDA GLP Regulations
  • Lesson 3: Review of the OECD Principles of GLP

Enrollment Period: 12 months
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