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.


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”.

Jordi Botet


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