Quality

2. Auflage 2022
ISBN: 978-0-323-90815-3
Verlag: Elsevier - Health Sciences Division

Buch, Englisch, 384 Seiten, Format (B × H): 192 mm x 227 mm, Gewicht: 820 g

Quality, second edition, provides comprehensive application of regulatory guidelines and quality concepts and methodologies related to pharmaceutical manufacturing. It is an excellent resource for practitioners, those pursuing pharmaceutical related certifications, and for students trying to learn more about pharmaceutical manufacturing. This book provides the background theory, applied descriptions of the guidelines and concepts, plus questions and problems at the end of the chapters that will help provide practice for the reader to apply the concepts.
In this book the authors share their combined 60+ years of extensive practical experience in the industry and in process improvement combined with detailed understanding of the needs of the industry and education system. This book provides real-life examples from industry and guidelines for practical application of tools that can be referenced by operators, engineers, and management.
This book is fully revised, updated, and expanded with new content in areas such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools.

Autoren/Hrsg.

Sanders, Janet H.

McCormick, Kathleen E.

Fachgebiete

• Wirtschaftswissenschaften Betriebswirtschaft Management Qualitätsmanagement, Qualitätssicherung (QS), Total Quality Management (TQM)
• Technische Wissenschaften Technik Allgemein Konstruktionslehre und -technik
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Biotechnologie
• Technische Wissenschaften Maschinenbau | Werkstoffkunde Produktionstechnik Industrielle Qualitätskontrolle
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Chemische Verfahrenstechnik

Inhaltsverzeichnis

1. Product Life Cycle 2. Good Manufacturing Practice 3. Elements of Quality Management 4. Quality Systems and International Standards 5. The Management of Quality 6. Inspections and Auditing 7. Quality Improvement Programmes 8. Corrective and preventive actions 9. Calibration 10. Validation 11. Technology Transfer 12. Water for Pharmaceutical Use 13. Pharmaceutical Microbiology 14. Good Distribution Practice

Über Autor(innen)

McCormick, Kathleen E.
Dr. Kate McCormick is a pharmaceutical manufacturing consultant and trainer who has worked extensively with both regulators and companies in more than 50 countries. She is the author of a number of textbooks, and she was an editor of GMP Review and International Education Advisor for ISPE. Dr. McCormick has a degree in biochemistry, a doctorate in microbiology, and is also a Master of Business Administration.

Sanders, Janet H.
Janet H. Sanders is an Associate Professor in the Department of Technology Systems at East Carolina University where her research focus includes quality, statistics, Lean Six Sigma, and process improvement methodologies. She has a BS in Ceramic Engineering, MS in Industrial Management, and a PhD in Industrial Engineering, and 30+ years of process improvement experience in various manufacturing, service, and healthcare industries.