Course Summary

The purpose of GLP is to provide assurance of the quality and reliability of nonclinical study data. GLP covers the planning, performance, monitoring, recording and reporting of studies. Regulatory authorities typically require GLP rules to be followed for nonclinical studies intended to support an application for approval of clinical research or marketing of a product containing the test item.

This course outlines the history of GLP and explains why it is important, identifies the penalties that may be incurred for noncompliance, and sets out requirements that need to be met. Learners are also referred to the two main sources of GLP rules: The Organisation for Economic Co-operation and Development’s Principles on Good Laboratory Practice and US Regulation 21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies.

Who will benefit from this module?

This module provides essential learning for all personnel of clinical/medical laboratories, especially those engaged in the examination of samples from subjects participating in clinical trials.

Learning Objectives

• Explain the purpose of Good Laboratory Practice (GLP) and describe the development of the US GLP Regulation and the OECD Principles of GLP
• Identify consequences of failure to comply with GLP
• Specify GLP requirements for laboratory organisation and the responsibilities of personnel
• Specify GLP requirements for the planning and performance of studies
• Specify GLP requirements for reporting of study results and the storage and retention of records and materials
• Identify typical findings of regulatory inspections of laboratories

Module Outline

Key topics covered in this module include:

• History and purpose of GLP
• Test facility organisation and personnel
• Planning and performance of studies
• Study Reporting and post-study considerations