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.
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.
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.
Inhaltsangabe
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
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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