Book Review - Project Management for the Pharmaceutical Industry

Project Management for the Pharmaceutical Industry

by Laura Brown and Tony Grundy

Reviewer: Paul Butler

The targets for this book, as stated in the Preface, include senior and middle management engaged in strategic projects and ‘pharmaceutical professionals managing projects within their own roles’. This would appear to cover all types of projects within a pharmaceutical environment but, in fact, the book concentrates on two very different types – clinical trials and strategic business development. There is very little about the many other types of projects typically handled within pharmaceutical companies. It is unfortunate that the title does not make it clear that such a narrow field of projects is addressed in the book.

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Book Review - Handbook of Pharmaceutical Excipients 7th Edition

Handbook of Pharmaceutical Excipients 7th Edition

Reviewer: Iain Moore

Excipients may well have no therapeutic effect in pharmaceutical dosage forms, but they are anything but innocent. Their inclusion is an essential part of the safe and effective delivery of the active ingredient to the patient. It is critical therefore that not only the properties of the excipients are understood but also the safety, interactions and typical functionality of excipients are known. Selection of excipients is therefore critical to the successful realisation of the medicinal product. The Handbook of Pharmaceutical Excipients has established itself as a leading reference work to acid this activity.

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Book Review - Computer Validation: A Common Sense Guide

Computer Validation:A Common Sense Guide

by Teri Stokes, Ph.D.

With the title “Computer Validation, A Common Sense Guide” my first thought was this book had to be a challenge to write, especially if the content lived up to the promise. While the requirement for Computer Validation has existed for the industry more than 25 years, in practice it is still often seen as a subjective and challenging activity – the intent of the book is to provide a practical approach for the process.

The main topics of this book of over 340 pages include a history of the regulations, explanations of the numerous roles and their responsibilities and required activities for successful outcomes, a large number of example documents, and principles and guidance from an author who has more than 20 years experience.

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Book Review - Quality by Design: Putting Theory into Practice

Quality by Design: Putting Theory into Practice

Editor: Siegfried Schmitt

This hardcover book of 360 pages, compiled by Siegfried Schmitt from PAREXEL Consulting, provides insight into the application of Quality by Design principles beyond the theory as described in the ICH guidelines on pharmaceutical development (Q8), quality risk management (Q9) and pharmaceutical quality systems (Q10).

In twelve chapters, four of which are authored by Dr Schmitt, a broad perspective is given on the applicability of Quality by Design principles in areas like process development and commercialisation, both for small molecules and biologicals, change management, process validation, microbiology and variations. This large array of topics is definitely a strength of the book, since it provides the reader different perspectives and explanations of the theoretical concepts in a practical setting.

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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.

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