Author: Jordi Botet

Good Quality Practice (GQP) in Pharmaceutical Manufacturing: A Handbook

eBook: US $129 Special Offer (PDF + Printed Copy): US $209
Printed Copy: US $145
Library License: US $516
ISBN: 978-1-68108-115-1 (Print)
ISBN: 978-1-68108-114-4 (Online)
Year of Publication: 2015
DOI: 10.2174/97816810811441150101


Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the starting and packaging materials through the manufacture of dosage forms until the safe reception of the finished product by the patient. The entire chain comprises of several processes: auditing, materials purchase (procurement), production, storage, distribution, quality control, and quality assurance.

The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)’, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation, however, requires a scientific approach and has to take into account several elements such as risk assessment, life cycle, patient protection, among other factors. Hence, pharmaceutical manufacturing is a complex subject in terms of regulation, given the technical and managerial requirements. This comprehensive handbook describes CGMP for new professionals who want to understand and apply the elements which build up pharmaceutical quality assurance. The book gives details about basic quality control requirements (such as risk management, quality hazards and management systems, documentation, clean environments, personnel training) and gives guidelines on regulatory aspects. This is an ideal handbook for undergraduates studying pharmaceutical or industrial manufacturing and supply chains as well for entrepreneurs and quality control professionals seeking to learn about CGMP standards and implementing quality assurance systems in the pharmaceutical sector.

Indexed in: Book Citation Index, Science Edition, EBSCO.


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 culture.

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.

Diana Amador-Toro
New Jersey


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