Thursday 5 June 2014

Book review: Pharmaceutical Regulatory Inspections

Pharmaceutical Regulatory Inspections  - Reviewed By Victor Grayson, Sterile Operations Manager, BPL (Pharmig News Number 60, p12)

Understanding the international regulatory field is an area of growing complexity and pharmaceutical facilities frequently face inspections from different global inspectorates, as well as their own national bodies. Keeping up with current Good Manufacturing Practices (GMP) can often be challenging.

To help with this complex task a new book has been produced “Pharmaceutical Regulatory Inspections”, edited by Madhu Raju Saghee. The book is timely, relevant and important.

The book contains chapters written by a number of international experts and covers everything anyone could possibly wish to know about the inspection process and quality issues affecting pharmaceuticals and healthcare.

In order to establish a baseline, the book opens with a very useful chapter by Tim Sandle and Madhu Raju Saghee which explores basic concepts of GMP and address global differences. The book then moves onto cover some key and specific topic areas including the FDA approach to GMP inspections; the current paradigm of ‘system based’ inspections and pre-approval inspections.

The book not only explains the inspection process, it also covers the key points that are likely to arise during an inspection or audit. This includes documentation, electronic systems, staff training, hygiene, licencing, compliance and so forth. The quality of the explanations is high and the book is packed full of useful examples and case studies.

Among the latter chapters of high quality is one by Siegfried Schmitt and Nabila Nazir which looks at the European inspection approach, breaking down the complexity of European regulations into a digestible format. Another useful chapter is where Tim Sandle, Madhu Raju Saghee and David Barr outline a strategy whereby organisations can respond to inspection observations in a timely, sensible and risk centric way.

For this reviewer the two gems of the book are the two closing chapters. One by Siegfried Schmitt and Richard Einig provides a survival guide for surviving inspections of API facilities; and another by Tim Sandle provides the most comprehensive guide for dealing with inspections of sterile facilities that this reviewer has ever come across.

In summary, this is an important book and it is an unique book. It is an essential item for the book shelf of anyone involved with quality inspections, audits or GMP.

Pharmaceutical Regulatory Inspections can be obtained from the publisher, Euromed

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