Introduction to Good Laboratory Practice (GLP)

Good Laboratory Practice (GLP) is a globally recognized quality system that ensures the reliability, integrity, and traceability of non-clinical laboratory studies. Regulatory authorities depend on GLP-compliant data to assess product safety before clinical trials can begin.

This course provides a practical introduction to GLP principles and their application in regulated laboratory environments.

What you’ll learn?

• Principles and purpose of GLP
• Role of GLP in non-clinical studies and drug development
• Responsibilities of laboratory personnel and Quality Assurance Units
• How to ensure reliable, compliant, and audit-ready laboratory data

Who should enroll?

• Laboratory personnel involved in non-clinical studies
• Quality assurance and quality control professionals
• Regulatory affairs specialists
• Study director
• Facility management
• Archivists
• Professionals working in pharmaceutical, biotech, or CRO laboratories

Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

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