| This book explains how to implement GxP-compliant quality systems in
clinical research. (GxP is a collective term for quality guidelines.)
The author, drawing from his extensive knowledge, provides a good selection
of examples and ideas of how to do this, not only to meet regulatory
requirements but to incorporate business quality improvements. It also
provides practical advice on how to prepare, update and maintain standard
operating procedures, as well as highlighting key activities that should
be monitored to help ensure compliance with the various regulations.
This book is aimed at anyone involved in clinical research quality systems,
such as those who work in quality assurance, audit and clinical research.
It is particularly aimed at clinicians involved in running clinical trials
in a non-commercial environment and those providing laboratory services
in university departments and hospitals. This book may also be relevant
to clinical research associates and pharmaceutical industry personnel.
As the title suggests, the author has tried to make this a practical
guide to setting up a management process for quality assurance. A number
of helpful forms, checklists and approaches are provided to facilitate
this. It is written in a friendly style which helps to liven up what
can be a rather dry subject.
Some of the book’s strengths include the practical nature of the
forms, checklists and methods, and the usefulness of the information
resources and acronyms section. Key GxP areas are covered, particularly
the good laboratory practice and good manufacturing practice aspects
of quality assurance for clinical trials.
Some areas of this topic are not covered in much detail in the book,
or at all, although the author does explain that he cannot cover everything.
It would have needed to be a much longer book to do this so this is just
a minor point. The book also focuses a great deal on the laboratory and
only mentions UK-specific legislation; if it is aimed specifically at
a UK market that is fine. The book is not aimed so much at the pharmaceutical
industry so the title could be misleading and it is less focused on good
clinical practice than one might have expected from the title of the
book. Also, on Figure 6.2, the type size is rather small to be able to
read easily.
Given the cost of advice on quality assurance I would say that the book
is good value for money.
Laura Brown (director of master of science studies in clinical research,
School of Pharmacy, University of Cardiff, and is an independent pharmaceutical
training and management consultant)
|
The
Pharmaceutical Journal