Good clinical, laboratory and manufacturing practices: techniques for the QA professional

Good clinical, laboratory and manufacturing practices: techniques for the QA professional  

P A Carson and N Dent (eds) 

Cambridge, UK: RSC Publishing |   2007 | 692pp: ?199.95 (HB) |  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.

Quality assurance for the analytical chemistry laboratory 

D Brynn Hibbert 

Oxford, UK: Oxford University Press | 2007 |  306pp | ?60.00 (HB) and ?32.99 (SB) ISBN 9780195162127 (HB); 9780195162134 (SB) 

Reviewed by Elizabeth Prichard

The need for reliable measurement results is increasing in areas as diverse as health care, environmental safety, trade and forensic science. Hence it is not surprising that we have another book dealing with quality assurance of chemical measurement. Hibbert’s one is based on the graduate course the author teaches at the University of New South Wales, Australia. 

It is tried and tested material in suited for graduate courses. It is not a text book, but the author provides the reasoning behind quality assurance - more the why than the how. In the introductory chapter the six VAM (valid analytical measurement) principles are given as a modern approach to quality in chemical measurement. Then all areas of quality assurance including experimental design are covered briefly with extensive further reading referenced.  

This book is well written with many personal touches, stories, anecdotes and unusual analogies introducing a lighter note. It would provide a very sound basis for any academic wishing to introduce a quality assurance course or to have close at hand to supplement other training material. The author at times, however, assumes his readers have an above average knowledge of the concepts, while in my opinion a few more examples would help less advanced students. I do not think there is sufficient detail to fill the gap for quality assurance managers who often have to learn ’on the job’. I also recommend that readers seek the opinion of the accreditation body in their own country, as interpretations of parts of ISO 17025 and GLP may be the author’s interpretation, or specific to Australia.