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

Introduction

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.

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)
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The Lifecycle Model

- Pp. 41-79 (39)
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Risk Management

- Pp. 81-117 (37)
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Quality Hazards in the Pharmaceutical Industry

- Pp. 119-158 (40)
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The Pharmaceutical Quality System: The 21st Century Approach

- Pp. 159-197 (39)
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Documentation

- Pp. 199-234 (36)
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Personnel and Training

- Pp. 235-268 (34)
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Premises/Clean Rooms

- Pp. 269-309 (41)
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Utilities

- Pp. 311-353 (43)
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Equipment

- Pp. 355-400 (46)
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Products

- Pp. 401-440 (40)
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Global Quality

- Pp. 441-484 (44)
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Bibliography

- Pp. 485-495 (11)
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Subject Index

- Pp. 497-503 (7)
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