handbook: good laboratory practice (glp): quality practices for
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H A N D B O O K
GOOD LABORATORYPRACTICE (GLP)
Quality practices for regulated non-clinical research and development
Special Programme for Research & Trainingin Tropical Diseases (TDR) sponsored by
U N I C E F / U N D P / W o r l d B a n k / W H O
Special 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 H O
WHO Library Cataloguing-in-Publication Data
Handbook: good laboratory practice (GLP): quality practices for regulated non-clinical research and development - 2nd ed.
1.Laboratories - organization and administration. 2.Laboratories - handbooks. 3.Laboratories techniques and procedures. 4.Manuals. I.UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases.
ISBN 978 92 4 154755 0 (NLM classification: QY 25)
Copyright World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases 2009
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Printed in Switzerland
Design: Lisa SchwarbLayout: OnProd, Lausanne
GOOD LABORATORY PRACTICE (GLP)
Quality practices for regulated non-clinical research and development
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 substantial 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 series is presented here in a revised and updated format. It supports continued tech-nology transfer and capacity-building in disease endemic countries (DECs) in line with the aims of the recent World Health Assembly Resolution (WHA 61.21) on a Global strategy and plan of action on public health, innovation and intellectual property (www.who.int/phi).
This Second-edition GLP Handbook contains all of the required support material for implementing GLP in a laboratory. The handbook comprises four parts, all updated, including: 1) explanation of the fundamentals of GLP; 2) support for GLP training; 3) meth-odology for GLP implementation in DEC research institutions; 4) GLP principles and guid-ance produced by the Organisation of Economic Co-operation and Development (OECD), and reproduced here with OECD permission.
Since publication of the initial GLP edition, TDR-fostered GLP training efforts throughout the world, and 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, and particularly in the creation of a section on stepwise implementation of GLP, identifying clear milestones for the process.
A key aim of TDR is to empower disease endemic countries to develop and lead research activities at internationally-recognized standards of quality. This revised GLP series will support that goal, assisting DEC institutions in performing research and drug development studies to international standards. 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.
GLP HANDBOOK Foreword
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 prod-ucts for the improvement of human health. In this way, the revised GLP series contributes to TDRs 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
ThE DEvElOpmEnT OF This hanDbOOk
To enjoy the advantages of new or improved methods for the control of tropical dis-eases, disease endemic countries (DECs) will need to rely to a large extent on their own research activities. It is therefore necessary to strengthen the capacity of these countries to conduct research and drug product development studies at a level comparable to that in other parts of the world.
The pertinent regulations in the preclinical scenario are the Good Laboratory Practice (GLP) regulations. These regulations are the subject of this handbook, which is a reference and support document, to help in the implementation of GLP. The Principles of Good Laboratory Practice of the Organisation for Economic Cooperation and Development (OECD) form the basis of this series of guidance documents.
This is the second version of the WHO Handbook on GLP. It is the result of experience gained since the first version was published. It also refers to material related to GLP devel-opments over the last seven years. Since the publication of the first GLP Handbook and training manuals, many training programmes have been conducted all over the world. The WHO-TDR Network of GLP Trainers was formed to continue propagating training and implementation of GLP in DECs. The network recommended the revision of this guidance document in order to reflect the progress in international GLP.
The modifications in this second version are as indicated below:
Chapter 1. Introduction to the WHO/TDR Handbook on GLP has been the subject of minor modifications to help understanding and facilitate reading.
Chapter 2. GLP Training: This has been reorganised and updated. The order of the five fundamental points now reads resources characterisation - rules results (instead of documentation) quality assurance. Minor corrections have been made and extra explanations added to this part dealing with the fundamentals of GLP.
Notable changes include: NewsectionontheroleoftheStudyDirectorintheMulti-Sitesituation. ReferencetotheprescriptiveanddescriptivedocumentsinGLPstudies. ReferencetoPrincipalInvestigators. ReferencetotheValidationofComputerisedSystems. NewsectionontheroleofQualityAssuranceintheMulti-Sitesituation.
GLP HANDBOOK The development
Chapter 3. Stepwise implementation now identifies clearer milestones in the process of setting up GLP, as requested by the GLP Network of Trainers.
Chapter 4. OECD guidance documents has been expanded to include those published since the first edition of the handbook. These represent entirely new items compared with the first version. At the time of going to press, all the OECD guidance documents on GLP are included in the handbook. The guidance documents are: theapplicationoftheOECDPrinciplesofGLPtotheorganisationandmanagement
of multi-site studies; theapplicationoftheprinciplesofGLPtoinvitroStudies; establishmentandcontrolofarchivesthatperateincompliancewiththeprinciples
Thus, this second edition of the GLP Handbook represents an up-to-date GLP reference document which we trust will be useful to support future deployment of GLP in research centres of DECs.
Contributors to the