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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
List 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.
