Book Reviews

Book Review - Quality in the manufacture of medicines and other healthcare products

Quality in the manufacture of medicines and other healthcare products

by John Sharp

For more than 40 years, John Sharp has played a key role in the development of European legislation for Good Manufacturing Practices. What we have in this second edition (suitably coloured Orange) is Sharp’s magnum opus. He conveys everything you need to know about the quality of manufactured medicines in a comprehensive yet compelling manner. It is a must read for anyone working in the field of Quality.

Whilst at first glance, it may appear as an extended version of the Orange Guide, it is actually so much more. In fact, there are eight detailed sections with expanded parts on sterile products, validation and risk management.

 It is impossible not to admire the depth and breadth of knowledge the author reveals in this volume. The anecdotes from his experiences nicely balance the learned with the conversational. The result is a book that builds on and reorganises the previous edition and also incorporates new material. The emphasis on people as the most important aspect of assurance of quality served a reminder to the reviewer: ‘Nothing, not even the finest premises, equipment, materials or procedures can compensate for the quality hazard represented by low standard, ill-trained or badly motivated staff’.

The wider implications of GMP/Quality are too often missed by organisations. Often, key individuals within Quality Departments seem to be driven by fear rather than by the assurance of quality. The chapter on ‘quality gurus’ is succinct and again underlines the human element to any quality system: ‘In a nut-shell, for medicinal products to be fit for their purpose, it is essential that the people involved in making them should themselves be fit for that purpose’. He delivers the section on Production planning in his ‘matter-of-fact’ style. Poor planning ultimately leads to ‘chaos inducing panic production’ which can have a serious impact on quality.

My only real criticism is that there is no mention of the recent legislative changes in the Clinical arena. The Clinical Trial Directive (2001/20/EEC) came into effect on the 1st May 2004. Since that time, GMP is necessary for investigational products. There is now a new role of a Qualified Person for Investigational Medicinal Products [QP(IMP)]. Individuals went through a ‘grandfather’ transitional arrangement until 2006. Annex 13 – the Manufacture of Investigational Medicinal Products was updated in 2009. The responsibilities for a QP(IMP) are different to a Permanent Provision QP but this seems to have been overlooked in the second edition.

There is, however, the update on GMP for Active Pharmaceutical Ingredients (APIs). What was Annex 18 has now become Part II: Basic Requirements for Active Substances Used as Starting Materials. The update is brief yet the adoption of this piece of legislation is proving to be a challenge for the industry. The onus is rightly placed on the pharmaceutical/medicines manufacturers to ensure that all principles of GMP are applied to active substances.

For those of us who work in the field of Quality, it is very easy to lose sight of the real objective, that is, “the safety, well-being and protection of the patient”. In all the madness around us, this book will serve as a timely reminder of what we are supposed to be doing.

Dave Sharma is a QP and also the Associate Director at Genzyme Europe.

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Published by PHSS 2011 (2nd Edition)

ISBN: 9781905271214

Paperback. 436 pages. Price £49.50