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Quality Assurance
Good clinical, laboratory and manufacturing practices: techniques for the QA professional
P.A. Carson and N. Dent (Eds.)
Cambridge, UK: RSC Publishing | 2007 | 692p | ISBN 9780854048342
Reviewed by J.A. Day
Carson and Dent remove much of the jargon and mystique often associated with quality assurance (QA) by drawing on the experience of a number of specialists in GxP (quality guidelines within pharmaceutical and clinical practice, including good laboratory practice (GLP), good clinical practice (GCP) and good manufacturing practice (GMP)).
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. The exceptionally well-presented chapters on the role of quality assurance, computing, inspections and standard operating procedures (SOPs) are particularly important in the modern laboratory.
Although meant for the GxP laboratory, it could easily be interpreted for ISO 17025 and ISO 9001 laboratories as well.
Many quality assurance manuals do not cover the subject in sufficient depth. Not this one. In over 600 pages, the authors cover purpose, control, documentation, history and training, as well as risk assessment, fit-for-purpose issues and the essential fundamentals of GxP systems, including the roles and responsibilities of those involved.
In summary, this is a well-structured, comprehensive and easy-to-read book on the individual parts of a GxP, aimed at quality managers and newcomers to quality assurance. 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, 2007.
Product Description
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.