TRAINING MANUAL - WHO

1 TRAINING MANUALGOOD LABORATORYPRACTICE (GLP)TRAINERS pecial Programme for research & Trainingin Tropical Diseases (TDR) sponsored byU N I C E F / U N D P / W o r l d B a n k / W H OSpecial Programme for research & TRAINING in Tropical Diseases (TDR) sponsored byU N I C E F / U N D P / W o r l d B a n k / W HOSECOND EDITIONWHO Library Cataloguing-in-Publication DataGood laboratory practice TRAINING MANUAL for the trainer: a tool for TRAINING and promoting good laboratory practice (GLP) concepts in disease endemic countries - 2nd - organization and administration. - handbooks. techniques and proce-dures.

2 Diseases - prevention and control. Bank/WHO Special Programme for research and TRAINING in Tropical 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 All rights use of content from this health information product for all non-commercial education, TRAINING and information purpos-es is encouraged, including translation, quotation and reproduction, in any medium, but the content must not be changed and full acknowledgement of the source must be clearly stated.

3 A copy of any resulting product with such content should be sent to TDR, World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland. TDR is a World Health Organization (WHO) executed UNICEF/UNDP/World Bank/World Health Organization Special Programme for research and TRAINING in Tropical use of any information or content whatsoever from it for publicity or advertising, or for any commercial or income-gen-erating purpose, is strictly prohibited. No elements of this information product, in part or in whole, may be used to promote any specific individual, entity or product, in any manner designations employed and the presentation of material in this health information product, including maps and other illustrative materials, do not imply the expression of any opinion whatsoever on the part of WHO, including TDR, the au-thors or any parties cooperating in the production, concerning the legal status of any country, territory, city or area, or of its authorities.

4 Or concerning the delineation of frontiers and or depiction of any specific product or commercial enterprise does not imply endorsement or recommendation by WHO, including TDR, the authors or any parties cooperating in the production, in preference to others of a similar nature not mentioned views expressed in this health information product are those of the authors and do not necessarily reflect those of WHO, including TDR. WHO, including TDR, and the authors of this health information product make no warranties or representa-tions regarding the content, presentation, appearance, completeness or accuracy in any medium and shall not be held liable for any damages whatsoever as a result of its use or application.

5 WHO, including TDR, reserves the right to make updates and changes without notice and accepts no liability for any errors or omissions in this regard. Any alteration to the original content brought about by display or access through differentmedia is not the responsibility of WHO, including TDR, or the authors. WHO, including TDR, and the authors accept no responsibility whatsoever for any inaccurate advice or information that is provided by sources reached via linkages or refer-ences to this health information : Lisa SchwarbLayout: OnProd, LausanneGOOD LABORATORY PRACTICE TRAINING MANUALfor the trainerA tool for TRAINING and promoting Good Laboratory Practice (GLP) concepts in disease endemic countriesiiiFOREWORDIn 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.

6 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 ) on a Global strategy and plan of action on public health, innovation and intellectual property ( ). 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 net-work of GLP trainers.

7 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 internation-ally-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 effi-cient preclinical research with a long-term positive effect on the development of products for the improvement of human health.

8 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 TDRvABOUT THIS TRAINING MANUALThis is the second editon of the WHO/TDR GLP TRAINING MANUAL for Trainers. It is a support document for the WHO Good Laboratory Practice (GLP) TRAINING Programme. The TRAINING is based on the Organization for Economic Cooperation and Development (OECD) GLP Principles which are recognized as the international standard for GLP.

9 The TRAINING is designed to be conducted over a three-day period. This MANUAL for trainers is part of a suite of three documents. These are:1. the WHO/TDR GLP Handbook (blue)2. the GLP TRAINING MANUAL for Trainers (red)3. the GLP TRAINING MANUAL for Trainees (green).All three documents have been updated at the same time in order to maintain to this MANUAL have come from many sources. The first version of this MANUAL could not have been compiled without the help of David Long, Nick Kail, David Ford, Nadya Gawadi and Phil Withers. However, this expanded second edition, initiated by the WHO/TDR Network of GLP Trainers includes contributions from all the people of the this second edition of the MANUAL we have reorganized the contents to align them with the five fundamental points developed in the Handbook.

10 Thus, after an introduction, the order of the five fundamental points is now: resources characterization rules results quality major difference seen in this edition is the additional material to be found in the seven appendices. This material is for optional use, depending upon the existing level of GLP knowledge of the trainees. This extra material is the result of experience from eight years of TRAINING since the publication of the first edition, and has been largely requested by the WHO/TDR GLP other major advance is in the number of optional workshops at the trainers disposal.