Handbook: Good laboratory practice
Overview
Quality practices for regulated non-clinical research and development
Summary
Good laboratory practices (GLP) are the recognized rules governing the conduct of non-clinical safety studies. They ensure the quality, integrity and reliability of the study data.
This handbook is designed as an aid for those countries wishing to upgrade their laboratories to GLP status. Based on the Organisation for Economic Cooperation and Development (OECD) principles of GLP, the aim of the handbook is to provide laboratories and trainers in disease-endemic countries with the necessary technical information for implementing GLP programmes.
The material in the handbook is presented in a clear and informative way. The introduction reviews the need for quality standards in drug research and development, and gives a history of GLP. Chapter 2 covers GLP training, and chapter 3, the stepwise introduction of GLP. The OECD principles of GLP and compliance monitoring are reprinted, with kind permission, in the annex section.