Good Lab Practice 2nd ed - J. Seiler (Springer, 2005) WW.pdf - lksfan

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

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

Good Lab Practice 2nd ed - J. Seiler (Springer, 2005) WW.pdf

Plik z chomika:

Inne pliki z tego folderu:

Inne foldery tego chomika: