TRAINING MANUAL

Special Programme for Research & Training in Tropical Diseases (TDR) sponsored by

UNICEF/UNDP/World Bank/WHO

TRAINING MANUAL

SECOND EDITION

GOOD LABORATORY PRACTICE (GLP)

TRAINER

WHO Library Cataloguing-in-Publication Data

Good laboratory practice training manual for the trainer: a tool for training and promoting good laboratory practice (GLP) concepts in disease endemic countries - 2nd ed.

1.Laboratories - organization and administration. 2.Laboratories - handbooks. 3.Laboratories techniques and procedures. 4.Manuals. 5.Endemic diseases - prevention and control. I.UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases.

ISBN 978 92 4 154756 7

(NLM classification: QY 25)

Copyright ? World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases 2008

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Design: Lisa Schwarb Layout: OnProd, Lausanne

GOOD LABORATORY PRACTICE TRAINING MANUAL for the TraineR

A tool for training and promoting Good Laboratory Practice (GLP) concepts in disease endemic countries

FOREWORD

In order to assist countries in conducting non-clinical research and drug development, TDR developed a Good Laboratory Practices (GLP) series in 2001, comprising a GLP Handbook as well as GLP Training manuals for trainers and trainees.

The demand for this series was so great that it became one of the most frequent "hits"

on the TDR website, generating interest and demand for a second edition. This second

edition GLP Training Manual for Trainers is presented here in a revised and updated format.

It supports continued technology transfer and capacity building in disease endemic coun-

tries (DECs) in line with the aims of the recent World Health Assembly Resolution (WHA

iii

61.21) on a Global strategy and plan of action on public health, innovation and intellectual property

(who.int/phi).

Since publication of the initial GLP edition, TDR-fostered GLP training efforts throughout the world (particularly in Asia, Latin America and Africa) have led to the formation of a network of GLP trainers. These trainers, acting as testers and critics, had a significant impact on the revision and expansion of this second edition GLP series.

A key aim of TDR is to empower DECs to develop and lead research activities to internationally-recognized standards of quality. This revised GLP series will support that goal, assisting DEC institutions in performing research and drug development studies. This, in turn, will also help institutions continue research initiatives into the clinical phases of development, in partnership with both the public and private sectors.

We anticipate that the use of these GLP resources will help promote cost-effective and efficient preclinical research with a long-term positive effect on the development of products for the improvement of human health. In this way, the revised GLP series contributes to TDR's primary mission of "fostering an effective global research effort on infectious diseases of poverty in which disease endemic countries play a pivotal role".

Dr R. Ridley Director TDR

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