Good Manufacturing Practices for Pharmaceuticals, Seventh Edition  book cover
7th Edition

Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

Edited By

Graham P. Bunn





ISBN 9781498732062
Published February 18, 2019 by CRC Press
385 Pages 50 B/W Illustrations

USD $199.95

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Book Description

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

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Editor(s)

Biography

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.