Introduction to Good Laboratory Practice (GLP)

The goal of non-clinical health and environmental safety studies is the generation of accurate data that can be put to use in making inferences as intended. It is expected that given the same materials and conditions, consistent results should be produced from such studies. GLP is a set of guidelines that protects the integrity and reliability of the results obtained from any of such laboratory studies. This is done by standardizing the preparation, methods, recording, processing, and archiving of data about these studies. This course introduces you to the concept of GLP starting at the history of the concept which points out why it was needed in the first place. You also get to see what role the OECD played in bringing it into existence and making it a global concept. Finally, you will learn how it applies to the stages of clinical trials whilst getting familiar with the fundamental points of GLP (Resources, Rules, Characterization, and Quality Assurance).

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Introduction

Lesson 1: The History of GLP

• GLP Regulations in 1979 and 1980
• First OECD Principles of GLP
• Globalization of GLP

Lesson 2: The Drug Development Process and The Role of GLP

• Phase 1
• Phase 2
• Phase 3
• Phase 4

Lesson 3: “Resources” as a Fundamental Point of GLP

• Organization and Personnel
• Facilities and Equipment

Lesson 4: “Rules” as a Fundamental Point of GLP

• Protocols
• Written Procedures
• The Study Director

Lesson 5: “Characterization” as a Fundamental Point of GLP

• The Test Item
• Test System

Lesson 6: “Quality Assurance” as a Fundamental Point of GLP

• Protocol (or Study Plan) Review
• SOP Review
• Planning
• Adults and Inspections

Glossary

Conclusion

Quiz