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.
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