Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA Professional - Hardcover

Hardcover

ISBN 10: 0854048340 ISBN 13: 9780854048342

Publisher: Royal Society of Chemistry, 2007

Synopsis

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.

About this title

About the Author

Dr Carson trained as an organic chemist (PhD) and safety and health expert (MSc). He was formally employed by Unilever as research scientist and Head of Science Support Services at their Research and Development Laboratory, Port Sunlight. Responsibilities included, occupational health, safety and environment; consumer safety; ethics of animal and human testing; Quality Assurance (GCP,GLP, GMP, ISO 14001/17025/OHSAS 18001); Project Risk Management and member of the Management Committee. Current posts include Quality Director (4-Front Research Ltd), a H&S consultant, Chairman of CIREC (a research ethics committee recognised for reviewing Phase 1 studies on healthy human volunteers) and member of a local hospital clinical ethics committees. Since 1983 he has been a member of the Institution of Chemical Engineers 'Loss Prevetion Panel' and is a member of the Association of Reserach Ethics Committee. He is past member of the Chemical Industries Association Health Advisory Group and past Chairman of their Hygiene Working Group. Bewteen 1990-2000 he was visiting lecturer in chemistry at UMIST and was PhD examiner for Aston University Chemical Engineering Department. He has over 60 technical publications including The Safe Handling of Chemicals in Industry (3 volumes), Longman The Hazardous Chemicals Handbook (2 editions), Butterworth Heinemann Good Clinical, Laboratory and Manufacturing Practices (2 editions), Royal Society of Chemistry He is also coauthor of 'Silver Screens of Wirral' (2 volumes), Countyvise Ltd

Review

Those involved in quality assurance and control could use the book as a reference guide and as a source of best-practice methodology to set up, operate, monitor and interpret a quality system....exceptionally well-presented.....s a well-structured, comprehensive and easy-to-read book.In nearly 30 years as an analytical chemist and quality professional, I have not come across a book that is a must-read, but this certainly is. (Chemistry World, November 2007, 74 (J A Day))

"This book should be essential reading for all those working QA" (Pharmazie in Unserer Zeit, Markus Veit, Kaufering.)

Edition details

• Publisher: Royal Society of Chemistry
• Publication date: 2007
• ISBN 10: 0854048340
• ISBN 13: 9780854048342
• Binding: Hardcover
• Language: English
• Edition number: 1
• Number of pages: 656
• Editor: Carson Philip, Dent Nigel