Good Manufacturing Practices for Pharmaceuticals, Seventh Edition
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Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

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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.
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Product details

  • Hardback | 371 pages
  • 178 x 254 x 25.4mm | 1,111g
  • Productivity Press
  • Portland, United States
  • English
  • New edition
  • 7th New edition
  • 50 Illustrations, black and white
  • 1498732062
  • 9781498732062
  • 1,760,762

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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About Graham P. Bunn

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.
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