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.