Quality in the manufacture of medicines and other healthcare products (2nd edn)

Quality in the manufacture of medicines and other healthcare products (2nd edn)
John Sharp
2011 | 436pp | ?49.50
ISBN 9781905271214
Reviewed by David Elder


This 2nd edition is a weighty tome with eight sections covering 436 pages. A common theme is that although the basics are covered well, there is a lack of recent references and the book struggles to provide a current commentary. Thus in chapter 2 (The concept of quality) the reader encounters several references to quality of design, but no mention is made of quality by design (QbD). 

Chapter 7 (The quality movement) is a frank disassembling of the quality guru movement. However, some significant aspects of Total Quality Management (TQM) and ISO 9000, particularly in risk management and change control, have been enthusiastically embraced by the industry. 

The largest section covers sterility and sterile products. Again the basics are covered well, but there are no current references (aside from regulatory guidance) to provide perspective to this important field (eg Michael Akers excellent text Sterile Drug Products). 

The most current section covers self inspection and includes a complete rewrite of the risk management chapter. Most of the risk assessment text is abstracted from the International Conference for Harmonisation quality topic 9 (ICH Q9) and it is comprehensively covered, especially the risk assessment tools. However, the author confesses his inability to advise on how current practitioners should implement, or perhaps reject, any or all of these tools. This startling admission highlights some of the shortcomings of the new edition. The absence of structured examples does make it difficult to breathe life into this subject area and without the preamble and direction offered by the US Food and Drug Administration’s GMPs for the 21st century this chapter lacks a clear focus. 

This book still covers the basic tenants of quality better than most, but the 2nd edition is less successful in fully covering the major quality challenges facing the pharmaceutical industry.