As a regulator, scientist, and expert in pharmaceutical quality, I am always searching for the best and most practical tools and reference material available in order to ensure pharmaceutical drug
quality. A challenge lies in keeping up with technological advances and frequent updates to the
information available. In today’s world technical information is so easy to obtain with a few
strokes of our fingertips. However, actually understanding and managing the information has
become a global challenge. In this age of information overload, it is difficult to determine what of
this vast information is actually required and how much understanding on the part of the
pharmaceutical personnel is needed to be utilized in practice.
What regulators, consultants, and industry all need is a sensible book that describes GMP topics
and international guidance in a simple manner, that both the layman and the expert could
understand and put to practical use. Such a book would ultimately benefit the global quality
This handbook responds to the needs previously articulated. It introduces the world of
pharmaceuticals in a manner that a layman would understand, but that an expert would also
appreciate. It describes GMP topics in a straightforward manner, providing clarity to frequently
discussed topics related to pharmaceutical quality and follows international guidance requirements
of “knowledge management,” and “continual improvement.”
I met the author in Estonia, at an International Pharmaceutical Quality Training Conference he was
attending, where I was an instructor. From the questions he asked and comments he made it was
evident he had extensive world-wide knowledge of Pharmaceutical GMPs. Whereas books in
general may not be as popular as they used to be when I was obtaining my education, this
handbook will be. It has a world-wide perspective and achieves its goal to provide a clear GMP
understanding in Good Quality Practices in Pharmaceutical Manufacturing.
Because of my work as a GMP-consultant I often travel and this allows me to meet people from
different countries all around the world. As a result I have come to understand how varied human
cultures are but also, curiously enough, how the concerns of the technicians from the
pharmaceutical industry are shared.
Thanks to modern technologies, the personnel of the pharmaceutical industry can easily obtain all
the necessary information. GMP regulations and associated guidance documents are readily
accessible and can be freely downloaded. Specialized literature and standards can be purchased on
line and often downloaded too. This means that technical information is immediately available in
almost anywhere in the world. In fact, getting informed has never been so easy…
Unfortunately there is a huge difference between having documents and being able to apply them
in practice. This is why the personnel of the pharmaceutical industry are deeply worried. The
amount of information is not only considerable but is also frequently updated. Coping with it is not
a straightforward matter. It is complicated for the average technician to develop manufacturing
activities and to spare enough time to read and “digest” the necessary documents. It is true that big
companies have many resources and can reduce the importance of this problem, but small and
medium-size firms are often extremely affected by it. According to my own practical experience,
basic doubts are very common and to be able to obtain a global vision and an integrated approach
of all the elements composing GMP is far from being widespread.
This book provides an answer to this common worldwide problem. It exposes GMP topics as
simply as possible. They are described in an integrated way and as straightforward and as practical
as possible. It responds openly to the “frequently asked questions” about hot topics such as the
Pharmaceutical Quality System, qualification, process validation, cleaning validation, lifecycle,
documentation, training, risk management, etc. Many tables and figures help in making the
description of these subjects clear and logical.
The global aim is to provide a clear GMP understanding to serve both to face practical everyday
manufacturing and to create a steady basis to acquire further knowledge. This follows the GMP
requirements of “knowledge management” and of “continual improvement”.
List of Contributors