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Good Laboratory Practice – the Why and the How
Jürg P. Seiler
Good Laboratory
Practice –
the Why and the How
With 38 Figures and 1 Table
1 3
Jürg P. Seiler
Hölzlistrasse 38
3475 Riedtwil
Switzerland
ISBN 3-540-25348-3 Springer-Verlag Berlin Heidelberg New York
Library of Congress Control Number: 2005923264
This work is subject to copyright. All rights are reserved, whether the whole or part
of the material is concerned, specifi cally the rights of translation, reprinting, reuse
of illustrations, recitation, broadcasting, reproduction on microfi lm or in any other
way, and storage in data banks. Duplication of this publication or parts thereof is
permitted only under the provisions of the German Copyright Law of September 9,
1965, in its current version, and permission for use must always be obtained from
Springer. Violations are liable to prosecution under the German Copyright Law.
Springer is a part of Springer Science+Business Media
springeronline.com
© Springer-Verlag Berlin Heidelberg 2005
Printed in the European Union
The use of registered names, trademarks, etc. in this publication does not imply,
even in the absence of a specifi c statement, that such names are exempt from the
relevant protective laws and regulations and therefore free for general use.
Product liability: The publishers cannot guarantee the accuracy of any information
about the application of operative techniques and medications contained in this
book. In every individual case the user must check such information by consulting
the relevant literature.
Editor: Thomas Mager, Heidelberg
Development Editor: Andrew Spencer, Heidelberg
Production Editor: Frank Krabbes, Heidelberg
Typesetting: Camera ready by the author
Cover design: design & production, Heidelberg
SPIN: 10966266
14/2109 fk – 5 4 3 2 1 0 – Printed on acid-free paper
Preface
After more than twenty years of use Good Laboratory Practice, or GLP,
has attained a secure place in the world of testing chemicals and other “test
items” with regard to their safety for humans and the environment. Gone are
the days when the GLP regulations were hotly debated amongst scientists in
academia and industry and were accused of stifling flexibility in, imaginative
approaches to, and science-based conduct of, all kinds of studies concerned
with toxic effects and other parameters important for the evaluation and
assessment of products submitted for registration and permission to market.
The GLP regulations have developed from rules on how to exactly document
the planning, conduct and reporting of toxicity studies to a quality system for
the management of a multitude of study types, from the simple determination
of a physical/chemical parameter to the most complex field studies or
ecotoxicology studies. At the same time the term “Good Laboratory Practice”
has become somewhat of a slogan with the aim to characterise any reliably
conducted laboratory work.
The 1997 revision of the OECD Principles of Good Laboratory Practice
has provided the reason to write this book and to present my views on GLP, to
explain the changes that GLP has undergone, and to put into perspective the
various possible interpretations of GLP requirements. The book is written not
only with the Study Director or the Quality Assurance Manager in a regulatory
environment as the target population in mind, but it is intended for, and
directed to, all quality-minded scientists, less so for lecturing them with the
exact interpretation of the strict requirements to be followed - as they have to
be rigorously obeyed in a test facility mandatorily working under GLP - but to
familiarise them with the intentions of GLP, to explain to them the real idea
behind these three letters. It is the opinion of the author that the application of
the GLP rules in other forms, adapted to specific situations - the PhD student
working on his or her thesis, the research group in academia or industry
scratching away at the frontier of science, or the central clinical-chemical
laboratory doing routine determinations in the context of a clinical study -
could help to increase the transparency, the quality and the integrity of any
scientific investigation. Certainly, there are other quality systems which may
be more suitable for some of these situations, but the idea behind the
regulations on Good Laboratory Practice, namely to ensure the complete
traceability of data and the full reconstructability of a study, would be
applicable with high rewards to a number of situations outside the “legal
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