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


by

Jordi Botet

DOI: 10.2174/97816810811441150101
eISBN: 978-1-68108-114-4, 2015
ISBN: 978-1-68108-115-1



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Indexed in: EBSCO.

Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the start...[view complete introduction]

Table of Contents

Foreword

- Pp. i

Diana Amador-Toro

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Preface

- Pp. iii

Jordi Botet

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Introducing the Particular World of Pharmaceuticals

- Pp. 3-40 (38)

Jordi Botet

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The Lifecycle Model

- Pp. 41-79 (39)

Jordi Botet

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Risk Management

- Pp. 81-117 (37)

Jordi Botet

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Quality Hazards in the Pharmaceutical Industry

- Pp. 119-158 (40)

Jordi Botet

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The Pharmaceutical Quality System: The 21st Century Approach

- Pp. 159-197 (39)

Jordi Botet

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Documentation

- Pp. 199-234 (36)

Jordi Botet

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Personnel and Training

- Pp. 235-268 (34)

Jordi Botet

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Premises/Clean Rooms

- Pp. 269-309 (41)

Jordi Botet

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Utilities

- Pp. 311-353 (43)

Jordi Botet

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Equipment

- Pp. 355-400 (46)

Jordi Botet

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Products

- Pp. 401-440 (40)

Jordi Botet

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Global Quality

- Pp. 441-484 (44)

Jordi Botet

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Bibliography

- Pp. 485-495 (11)

Jordi Botet

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Subject Index

- Pp. 497-503 (7)

Jordi Botet

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Foreword

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
Parsippany
New Jersey
USA


Preface

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
Barcelona
Spain
E-mail: jbotetfregola@gmail.com

List of Contributors

Author(s):
Jordi Botet
Barcelona
Spain




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