The Good Laboratory Practice (GLP) Handbook is designed to serve as an aid for those countries who wish to upgrade their laboratories to GLP status. It has been developed as part of a significant and wide-ranging technology transfer and capacity building programme in the area of pre-clinical product development for disease endemic countries.

The GLP Handbook has been produced by a Scientific Working Group (SWG) on GLP issues, convened by the UNDP / World Bank / WHO Special Programme for Research & Training in Tropical Diseases (TDR), which consisted of independent scientific specialists from around the world. The Handbook is broadly based on the Organisation for Economic Cooperation and Development (OECD) principles of GLP.

The Handbook will provide laboratories in disease endemic countries, and trainers throughout these nations, with the necessary technical aid for implementing GLP programmes. TDR gratefully acknowledges the participation and support of all those involved in the production of this Handbook and, in particular, the OECD who also kindly permitted reprint of both the OECD Principles of Good Laboratory Practice and the related documents.

FORWARD:

Good laboratory practices (GLP) are recognized rules governing the conduct of non-clinical safety studies, ensuring the quality, integrity and reliability of their data. To introduce the concepts of GLP to scientists in developing countries, workshops on GLP have been organized in these regions. As an outcome of the workshops, it became apparent that some formal guidance would be needed for the successful implementation of the GLP standards.

The first scientific working group on GLP issues was convened on 25 November, 1999, in Geneva, to discuss quality issues in general and the necessity for a WHO guidance document on GLP in particular. The working group concluded that it was important to avoid the co-existence of two GLP standards, the Principles of Good Laboratory Practice of the Organization for Economic Cooperation and Development (OECD) being the internationally recognized and accepted standard, and recommended that the OECD Principles be adopted by WHO/TDR as the basis of this guidance document.

The experts also recognized the need to address quality issues in areas other than the strictly regulated safety studies for regulatory submission, and recommended that some explanation be included in this guidance document.

The working group further recommended that:

• WHO/TDR should request OECD’s permission to publish the existing OECD GLP text with a WHO endorsement, and to supplement it with an explanatory introduction.

• WHO/TDR should promote/participate in GLP training in various regions of the world.

• WHO/TDR should prepare a guideline on the practical implementation of GLP in laboratories.

• WHO/TDR should prepare a volume containing:
– Explanatory text to GLP.
– OECD Principles of GLP.
– Important issues in the performance of studies that fall outside of the GLP remit.
– Need for, and development of, compliance monitoring systems.
– Financial considerations of GLP implementation.
– Training and education package(s).
– Guide to stepwise implementation of GLP.

At its second meeting (Geneva, 4-6 September, 2000), the scientific working group on GLP issues discussed the material which had been prepared in the meantime. It concluded that it was not possible to address issues of quality both within and outside of the regulated sector of drug development and testing, in one and the same document.

It therefore recommended that:
• Two documents should be developed from the proceedings of the meeting. These documents would address the quality of research data but at different levels, i.e. nonregulatory and regulatory (GLP).
• The first document should contain all sections dealing with GLP and should be published as soon as ready.
• A second document, addressing quality issues in biomedical research in general, should be produced as a draft and be circulated for comments.

The present WHO Handbook on GLP is the result of these deliberations, and it addresses aspects of regulatory safety studies which are covered and governed by the OECD Principles of GLP. The quality aspects of studies outside this regulated area (e.g. basic research, early development) will be discussed on a broader basis and are therefore not included here.

Visit The Good Laboratory Practice (GLP) Handbook Download Page

Quality practices for regulated non-clinical research and development

UNDP/World Bank/WHO
Special Programme for Research and Training in Tropical Diseases (TDR)

Download The Good Laboratory Practice (GLP) Handbook

PDF format, 1.12MB, 226Pages.

The Special Programme for Research and Training in Tropical Diseases (TDR) is an independent global programme of scientific collaboration. Established in 1975 and co-sponsored by the United Nations Children's Fund (UNICEF), the United Nations Development Programme (UNDP), the World Bank and the World Health Organization (WHO), it aims to help coordinate, support and influence global efforts to combat a portfolio of major diseases of the poor and disadvantaged.

TDR focuses on neglected infectious diseases that disproportionately affect poor and marginalized populations.

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