Written by a team of world experts the book provides practical and detailed advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of pre-clinical safety studies, clinical trials and manufacture of drugs. It provides a framework for integrating these standards with other quality management systems. Detailed examples are provided to illustrate application of the principles.
The book is targeted primarily at all those subjected to internal and external inspection and audit for compliance with the requirements of good clinical, good laboratory, and good manufacturing practices. It will be of value to chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians, and toxicologists. The section on harmonisation of quality systems is also of value to safety, health, and environment advisors.
It is a source of authoritative reference and training material on research and manufacturing quality for the chemical, cosmetic, and pharmaceutical industries, and in contract research organisations, universities and government establishments.

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Philip Carson; Nigel Dent; Fergus Sweeney; Tim R Stiles; Pamela Nickols; Rosemarie Corrigan; Patricia Fitzgerald; Judith Janssens; Laura Brown; Sue Eckstein; David Bailes; Sue Ollier; Paul Rolan; Roger Cope; Paddy Ford

P. A Carson; N. J Dent; Royal Society of Chemistry (Great Britain)

Phillip Carson, Chemiker; N Dent

Phillip A. Carson; Nigel J. Dent

edited by P.A. Carson, N. Dent

Adobe Acrobat 7.1

Royal Institute of Chemistry

The Chemical Society

Lightning Source Inc. (Tier 3), Cambridge, 2007

United Kingdom and Ireland, United Kingdom

Cambridge, England, 2007

Reprint, Cambridge, 2007

0

lg237348

producers:
Adobe Acrobat 7.1 Image Conversion Plug-in

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Includes bibliographical references and index.

cover.jpg......Page 1
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<p>Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.</p>

Spanning chemical, cosmetic and manufacturing industries, this book is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists.

2010-02-18