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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 proce. dures 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, All rights reserved. The 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 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 Diseases, The 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 whatsoever. The 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 or concerning the delineation of frontiers and borders. Mention 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 or, The 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 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 different. media 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 product, 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, 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. www 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 net. work 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 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 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, ABOUT THIS TRAINING MANUAL. This 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 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 v, All three documents have been updated at the same time in order to maintain consistency.
Contributions 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 network. In this second edition of the manual we have reorganized the contents to align them. with the five fundamental points developed in the Handbook Thus after an introduction. the order of the five fundamental points is now, characterization. quality assurance, The 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 Trainers, The other major advance is in the number of optional workshops at the trainers disposal. Depending upon local conditions or requirements the trainer can select from the available. workshops to suit needs For the convenience of copying the workshops have been. removed from the training manual and are now available in the accompanying CD. traineR About this training manual, The training material is divided into two parts 1 presentation materials which are in the. present volume and 2 workshop materials which are only available in the CD There is too. much material for it all to be used in a single three day training course As a trainer you will. have been trained under the auspices of the WHO or you are already a recognized expert. in GLP You should therefore present the core material chapters 1 6 and then select any. additional presentations or workshop materials on the basis of local needs. Presentation material, There are six chapters and seven appendices each one dealing with a separate topic for.
presentation The six chapters cover the essential core topics which you should use for all. training courses The appendices provide optional presentation material Each of the. vi chapters and appendices has the same format, Section summary. As the trainer you will already have this knowledge but it is worth reading through this. section before starting a presentation to fix the salient points in your mind You should. encourage the participants to read these sections between presentations for the same. reason They are included in the trainee s manual green book. Slide presentation, The slides are for your presentations The trainees have a copy of the same slides in their. manual so they will only need to make additional personal notes Many of the slides have. instructions in the form of instructor s notes to help you through the presentation These. draw attention to the message of the slide and occasionally suggest how you could usefully. engage the group in discussion Naturally the trainees do not have these notes. Workshop material, The workshops are group activities There are no hard and fast rules about the solutions to. workshop issues and you will have to take each proposal from each group as a point for discus. Developing a good rapport with the trainees during the training session is of utmost. importance You should always be positive never dismiss as unacceptable the group response. to the workshop tasks Find out why they have decided to make the suggestion that they put. forward The reason may be well founded even if the response seems to be non compliant. Finally always try to relate what the groups have to say to the fundamental points of GLP. ACKNOWLEDGEMENTS, The Good Laboratory Practice GLP Training Manual set comprises of two manuals. one for the trainer red one for the trainee green These have been designed for use as. an introductory course to GLP They are accompanied by a WHO TDR Handbook on GLP. blue which includes an introduction to GLP texts concerning the salient points of the. GLP Principles and suggestions on how to implement GLP in laboratories The handbook. also includes all 15 of the OECD guidance documents on GLP WHO TDR is particularly. grateful to the OECD for permission to reproduce these documents in extenso. This second edition of the Training Manual was made possible by the enthusiastic sup. port and contributions of the WHO TDR Network of GLP Trainers The manuals were vii. written by David Long based on material which existed in the first editon and on the. input from the many international GLP training sessions and workshops organized by the. WHO TDR Preclinical Coordinator since the inception of the training programme in. Particular thanks should be extended to the WHO TDR Network of GLP Trainers who. have contributed to this version and have given unflagging support to the project. It is hoped that the training manuals will continue to provide a valuable tool for training. and promoting GLP implementation in the DECs, Comments and suggestions on all aspects of these manuals are welcome for.
consideration in future revisions Please contact, Dr Deborah Kioy. Preclinical Coordinator, Avenue Appia 20, 1211 Geneva 27 Switzerland. Tel 41 22 791 3524, Fax 41 22 791 4854, E mail kioyd who int. TABLE OF CONTENTS, 1 INTRODUCTION TO THE OECD PRINCIPLES OF GLP 1. INTRODUCTION 1, THE FUNDAMENTAL POINTS OF GLP 2, THE OECD GLP PRINCIPLES 4.
2 RESOURCES 13 ix, MANAGEMENT 13, PERSONNEL 15, FACILITIES BUILDINGS AND EQUIPMENT 17. 3 CHARACTERIZATION 49, THE TEST ITEM 49, THE TEST SYSTEM 57. 4 RULES 71, THE PROTOCOL OR STUDY PLAN 71, STANDARD OPERATING PROCEDURES SOPs 76. 5 RESULTS 97, RAW DATA AND DATA COLLECTION 97, FINAL REPORT 100. ARCHIVING 102, Indexing 104, 6 QUALITY ASSURANCE 119.
PROTOCOL OR STUDY PLAN REVIEW 119, SOP REVIEW 120, PLANNING MASTER SCHEDULE INSPECTION PLAN 120. AUDITS AND INSPECTIONS 120, QUALITY ASSURANCE STATEMENT 123. QA INSPECTIONS OF SUPPLIERS AND CONTRACTORS 124, ISSUING AND ARCHIVING OF QA FILES AND REPORTS 124. APPENDIX 1 THE OECD AND ITS GLP ACTIVITIES 133, APPENDIX 2 GLP AND MANAGEMENT 157. APPENDIX 3 GLP AND THE STUDY DIRECTOR 173, APPENDIX 4 GLP and the Multi Site Studies 191.
APPENDIX 5 GLP and Short Term Studies 205, APPENDIX 6 GLP AND COMPUTERIzeD SYSTEMS 219. APPENDIX 7 GLP AND in vitro STUDIES 239, 1 INTRODUCTION TO THE OECD. PRINCIPLES OF GLP, INTRODUCTION, Good Laboratory Practice GLP regulations became part of the regulatory landscape in. the latter part of the 1970s in response to malpractice in research and development R D. activities by pharmaceutical companies and contract facilities used by them. The malpractice included cases of fraud but by far the most important aspects were the 1. lack of proper management and organization of studies performed to generate data for. regulatory dossiers The US Food and Drug Administration FDA mounted a series of. investigations in toxicology laboratories throughout the USA The results of these investi. gations revealed a situation that could only be dealt with by imposing binding regulations. These regulations are the GLP regulations GLP regulations were first instituted by US. FDA then by US Environmental Protection Agency EPA many other nations have since. 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 proce dures 4 Manuals 5 Endemic diseases prevention and control I UNDP World Bank WHO Special Programme for

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