Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

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.

• PrefaceEditorContributors1. Status and Applicability of U.S. Regulations: CGMPGraham P. Bunn2. Quality Management Systems and Risk ManagementJoseph C. Near3. Management Responsibility and ControlJohn E. Snyder4. Organization and PersonnelGraham P. Bunn and Joanna B. Gallant5. Finished Pharmaceuticals: General ProvisionsGraham P. Bunn6. Production and Process ControlsJocelyn A. Zephrani7. Records and ReportsGraham P. Bunn8. Clinical Trial SuppliesDavid Stephon9. Contracting and OutsourcingJoseph C. Near10. Buildings and FacilitiesRobert Del Ciello11. EquipmentRobert Del Ciello and Joseph T. Busfield12. Control of Components and Drug Product Containers and ClosuresGraham P. Bunn13. Holding and DistributionAndrew Acker14. Returned and Salvaged Drug ProductsGraham P. Bunn15. Active Pharmaceutical IngredientsJoseph C. Near16. Pharmaceutical Excipient Good Manufacturing PracticesIrwin Silverstein17. Packaging and Labeling ControlGraham P. Bunn18. Laboratory ControlsAlex M. Hoinowski19. Microbiological Aspects of Pharmaceutical Aseptic Processing in the Compounding PharmacyDawn McIver20. CGMP Enforcement Alternatives in the United StatesDaniel G. Jarcho and Cathy L. Burgess21. FDA Inspection ProcessCathy L. Burgess and Daniel G. Jarcho22. FDA Pre-approval InspectionsCathy L. Burgess, Justin Mann, and Seth Olson23. Worldwide Good Manufacturing PracticesDominic Parry24. Data Integrity and Fundamental ResponsibilitiesRandy Hightower and Michele PruettIndex

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 PharmaceuticalBrilliant !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 ConsultantGood 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 RobertsSenior Director Regulatory Complianceex-FDA