This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.
Key Features:
- Presents insight into the world of pharmaceutical quality systems
- Analyzes regulatory trends and expectations
- Includes approaches and practices used in the industry to comply with regulatory requirements
- Discusses recent worldwide supply chain issues
- Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry
Table of Contents:
Preface
Editor
Contributors
1. Status and Applicability of U.S. Regulations: CGMP
Graham P. Bunn
2. Quality Management Systems and Risk Management
Joseph C. Near
3. Management Responsibility and Control
John E. Snyder
4. Organization and Personnel
Graham P. Bunn and Joanna B. Gallant
5. Finished Pharmaceuticals: General Provisions
Graham P. Bunn
6. Production and Process Controls
Jocelyn A. Zephrani
7. Records and Reports
Graham P. Bunn
8. Clinical Trial Supplies
David Stephon
9. Contracting and Outsourcing
Joseph C. Near
10. Buildings and Facilities
Robert Del Ciello
11. Equipment
Robert Del Ciello and Joseph T. Busfield
12. Control of Components and Drug Product Containers and Closures
Graham P. Bunn
13. Holding and Distribution
Andrew Acker
14. Returned and Salvaged Drug Products
Graham P. Bunn
15. Active Pharmaceutical Ingredients
Joseph C. Near
16. Pharmaceutical Excipient Good Manufacturing Practices
Irwin Silverstein
17. Packaging and Labeling Control
Graham P. Bunn
18. Laboratory Controls
Alex M. Hoinowski
19. Microbiological Aspects of Pharmaceutical Aseptic Processing in the Compounding Pharmacy
Dawn McIver
20. CGMP Enforcement Alternatives in the United States
Daniel G. Jarcho and Cathy L. Burgess
21. FDA Inspection Process
Cathy L. Burgess and Daniel G. Jarcho
22. FDA Pre-approval Inspections
Cathy L. Burgess, Justin Mann, and Seth Olson
23. Worldwide Good Manufacturing Practices
Dominic Parry
24. Data Integrity and Fundamental Responsibilities
Randy Hightower and Michele Pruett
Index
About the Author :
Graham P. Bunn is the president of GB Consulting LLC, in Pennsylvania, a company providing regulatory compliance, quality systems, regulatory action remediation, training and technical consulting services for pharmaceutical, biotechnology and other FDA and European Medicines Agency (EMA)-related industries. Before founding GB Consulting LLC, Graham experienced broad good manufacturing practices (GMP) and FDA inspection experience through his work in the pharmaceutical industry, including working for SmithKline Beecham PLC (GlaxoSmithKline PLC), Wyeth Pharmaceuticals (Pfizer), and Astra Merck Inc. (AstraZeneca PLC). His career experience includes management positions and responsibilities as a corporate quality auditor and in quality assurance, validation, and clinical trials manufacturing and packaging. He has developed and facilitated numerous highly interactive learning and training workshops worldwide. Graham is also the author of several book chapters and journal articles. A member of the Regulatory Affairs Professional Society (RAPS). Graham received a BSc in pharmacy from Brighton University, England, and an MSc in quality assurance and regulatory affairs from Temple University, in Philadelphia.
Review :
I was very gratified with the overall format of this GMP Book. Concept is easy to read and follow. And tracked correctly. The purpose of this amazing book is very obliging. This book assures that all new and existing personnel will be able to understand their specific role. Highly recommended GMP book!
Rosemarie Taruc, MQA Pharmaceutical
Brilliant !
The seventh edition of Good Manufacturing Practices for Pharmaceuticals is an invaluable resource for anyone in the pharmaceutical industry. It presents a clear and easy-to-understand guide that caters to both beginners and experienced professionals alike. The book effectively breaks down complex concepts, making them accessible to all readers. Additionally, it serves as an excellent reference for understanding regulations, particularly FDA expectations regarding CGMP and 21 CFR Part 210 & 211. Whether you’re new to the field or looking to refresh your knowledge, this book is a must-have for ensuring compliance and promoting best practices in manufacturing. It’s an excellent resource for all pharmaceutical companies to add to their curriculum. Cannot wait for the next edition.
Juan P Calderon Pharmaceutical QA
Good Manufacturing Practices for Pharmaceuticals (Seventh Edition) is a highly recommended read if you’re looking for a comprehensive overview of the regulatory processes and cGMP. Despite your experience or expertise, this book is guaranteed to expand your knowledge about the different aspects of the pharmaceutical industry and what the manufacturing process entails. Considering the lives at risk, every pharmaceutical company and their associated partners are expected to be well-oiled machines who consistently provide safe and effective drugs. A lack of compliance and understanding in just one area can cause a waterfall of effects throughout the lifecycle of any drug. If you’re looking for a resource tool for yourself, your employees, or even to just enlighten your friends and family on the intricacies of manufacturing pharmaceuticals, this book is a must have.
P. Persaud QA, Aseptic CDMO
The Good Manufacturing Practices for Pharmaceuticals, Seventh Edition, edited by Graham P. Bunn, is an invaluable resource for professionals in the pharmaceutical industry. The book provides a comprehensive examination of key areas of current Good Manufacturing Practices (CGMP), as outlined in 21 CFR Part 211. Covering essential topics such as quality control, production processes, equipment, and record-keeping, it is indispensable for ensuring compliance with regulatory requirements. It also addresses critical areas such as personnel qualifications, sanitation, and contamination control, which are integral to maintaining the safety and quality of pharmaceutical products.
This edition delves into specific CGMP requirements for manufacturing, packaging, labeling, and distribution, reflecting the standards set forth in CFR 211. Its clear and accessible approach makes it a valuable guide for both beginners and experienced professionals, helping them navigate and implement CGMP practices effectively.
The book's well-organized format and ease of comprehension make it highly recommended. It breaks down complex concepts and serves as an excellent reference for understanding FDA expectations regarding CGMP and 21 CFR Parts 210 & 211. Regardless of one's level of experience or expertise, this book will undoubtedly enhance knowledge about various aspects of the pharmaceutical industry and the intricacies of the manufacturing process.
Overall, this seventh edition is an indispensable reference that keeps pace with evolving standards in pharmaceutical manufacturing. It is a resource to return to repeatedly for guidance and clarification, making it essential for ensuring compliance and promoting best practices in the industry.
José de la Vega, CGMP Consultant
Good Manufacturing Practices for Pharmaceuticals, Seventh Edition by Graham Bunn is a comprehensive and updated guide to GMP regulations and their application in the pharmaceutical industry. The book covers essential topics such as quality management, documentation, validation, and regulatory compliance, making it an invaluable resource for professionals in manufacturing, quality assurance, and regulatory affairs.
Bunn provides clear explanations of global GMP standards, including FDA, EMA, and WHO guidelines, helping readers understand the evolving landscape of pharmaceutical compliance. The seventh edition includes the latest industry developments, ensuring relevance to modern manufacturing practices. With practical insights and real-world applications, the book serves as both a reference guide and a training resource. While technical at times, its structured approach makes complex regulations more accessible. Overall, this edition is an essential tool for ensuring pharmaceutical product quality and regulatory adherence, making it a must-read for industry professionals.
Dan Roberts
Senior Director Regulatory Compliance
ex-FDA
