Book Reviews

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.

The other side of the coin is that it is difficult for the reader to get a full grasp of the theoretical concepts such as control strategy, design of experiments and design space. This is partially overcome by an index allowing for bringing together text on these concepts often scattered over tens of different locations in the book. Some of the concepts such as the use of knowledge management and the lifecycle approach have been more concentrated in single chapters.

The book demonstrates that there are no limitations to the use of QbD approaches at different aggregation levels as is demonstrated in a chapter indicating how to run an entire laboratory using QbD principles. Also illuminating is the chapter bringing compliance and the science and risk based approaches of QbD together into the new concept of Compliance by Design (CbD), for instance leading to the definition of CbD critical compliance parameters and encompassing a lifecycle approach towards compliance.

Overall the book is well written, although I would have liked to see more input from regulators involved with the start of the paradigm change like Ali Afnan and Ajaz Hussain. Such authors could not only have provided more historical background information, but also provided the outsiders' perspective why the pharmaceutical industry had to change and in which direction. Also remarkable is that hardly any experts and thought leaders from big pharma have been involved in authoring the chapters of this book, which makes one wonder whether these companies would have different insights into the translation of theoretical QbD concepts into practice. Except for Abbott and Novo Nordisk contributions, no QbD leading companies like Baxter, Eli Lilly, GSK, Lonza Biologicals, Merck Serono, Novartis, Pfizer, or Roche was involved.

To some extend this argument is counteracted by the fact that many of these companies are active in either the ISPE PQLI or the PDA PCMO initiatives, and input from these initiatives is reflected in this book as well.

Some final words about the printing quality of the book. My impression is that it has been produced in a hurry and in a cheap way, especially noticeable when I had difficulty in reading some of the figures and computer drawings.

In conclusion, I believe the book avoids the pitfall of presenting uniform cookery book recipes for QbD, but serves its purpose of delivering QbD practical examples, which should enhance understanding of the concept and further in-depth company discussions. This eventually should lead to better QbD implementation.

Tom Sam, PhD, is Head of Global CMC Regulatory Affairs at Merck Sharp and Dohme, The Netherlands.

Co-published by PDA 2011

ISBN: 1933722487

Hardback 360 pages.   Price $259.00