2. Good Laboratory Practice Training

Introduction

The history and scope of GLP are discussed in chapter 1 of this WHO/TDR Handbook on GLP. This present part (chapter 2) of the Handbook is intended to supplement the WHO/TDR training manuals and should be used in conjunction with them.

Regulatory GLP started when the Food and Drug Administration (FDA) issued mandatory GLP requirements. These came into force on 20th June 1979. They were a reaction to cases of malpractice and fraud in the non-clinical testing of drugs performed by some pharmaceutical companies and contract research organisations. Subsequently the FDA revised these regulations a number of times but their scope remains the same: the regulations

still apply to non-clinical studies used to evaluate safety. Preliminary pharmacological studies and pharmacokinetic studies not designed to test safety are thus exempt from GLP requirements. A little later, in 1981, the Organisation for Economic Cooperation &Development (OECD) issued Principles for GLP concerning the safety testing of any chemical substance. These Principles were revised in 1997 to reflect more recent developments. Each of the thirty OECD member states has agreed to accept the data from safety studies performed by any other member state provided that they have been conducted in compliance with the OECD GLP Principles. The OECD GLP Principles have, therefore, gradually dominated GLP world-wide. The world-wide acceptance of the OECD Principles was even more accentuated when the OECD issued a Council Decision on the voluntary adherence of Non-Member States. The fact that the OECD GLP Principles have acquired wide international acceptance is the reason why they are used as the reference guide for the WHO/TDR GLP training programme. WHO/TDR wishes to thank the OECD Directorate for Environment for allowing the publication in extenso of the OECD GLP documents in this Handbook (Annexes).

The WHO/TDR effort to promote the development of therapeutic substances against tropical diseases and the conduct of studies in DECs is a matter of high priority. For studies to be readily accepted by regulatory authorities world-wide GLP implementation in laboratories conducting non-clinical safety studies is of major importance. Part of achieving this goal in regions where there is limited knowledge of and experience with formal quality concepts like GLP is to promote “technology” or “knowledge transfer”, through the training of scientists, thus enabling them to work in compliance with these standards. Therefore, WHO/TDR is actively promoting training courses designed to provide an understanding of the concepts of GLP and to facilitate the practical implementation and application of these principles.

The WHO/TDR GLP training course in GLP is seen as an enabler aiming to assist institutes in Disease Endemic Countries (DECs) to reach GLP compliance thus allowing them

to increase the international credibility of their data and results. Therefore, this GLP training contributes pertinently to capacity building in DECs which is one of the specific aims of WHO/TDR.