8th Edition
Good Manufacturing Practices for Pharmaceuticals
Preface
Contributors
About The Editor
Chapter 1: Status and Applicability of U.S. Regulations: CGMP
Graham P. Bunn
Chapter 2: Quality Management Systems and Risk Management
Joseph C. Near
Chapter 3: Management Responsibility and Control
John E. Snyder
Chapter 4: Organization and Personnel
Graham P. Bunn, Joanna B. Gallant
Chapter 5: Finished Pharmaceuticals: General Provisions
Graham P. Bunn
Chapter 6: Production and Process Controls
Jocelyn A. Zephrani
Chapter 7: Records and Reports
Graham P. Bunn
Chapter 8: Clinical Trial Supplies
David Stephon
Chapter 9: Contracting and Outsourcing
Joseph C. Near
Chapter 10: Buildings and Facilities
Robert Del Ciello
Chapter 11: Equipment
Robert Del Ciello, Joseph T. Busfield
Chapter 12: Control of Components and Drug Product Containers and Closures
Graham P. Bunn
Chapter 13: Holding and Distribution
Andrew Acker
Chapter 14: Returned and Salvaged Drug Products
Graham P. Bunn
Chapter 15: Active Pharmaceutical Ingredients
Joseph C. Near
Chapter 16: Pharmaceutical Excipient Good Manufacturing Practices
Irwin Silverstein
Chapter 17: Packaging and Labeling Control
Graham P. Bunn
Chapter 18: Laboratory Controls
Alex M. Hoinowski
Chapter 19: FDA Inspections of 503A Compounding Pharmacies and 503B Outsourcing Facilities
Stephanie A. Slater and Daniel J. Roberts
Chapter 20: CGMP Enforcement Alternatives in the United States
Daniel G. Jarcho, Cathy L. Burgess
Chapter 21: FDA Inspection Process
Cathy L. Burgess, Daniel G. Jarcho
Chapter 22: FDA Pre-approval Inspections
Cathy L. Burgess, Justin Mann, Seth Olson
Chapter 23: Best Practices for the Pharmaceutical Industry: FDA Guidance on Refusing an Inspection
Daniel J. Roberts and Stephanie A. Slater
Chapter 24: The Qualified Person in the Pharmaceutical Industry
Adrian Chowdhary
Chapter 25: Data Integrity and Fundamental Responsibilities
Randy Hightower, Michele Pruett
Index
Biography
Graham P. Bunn has been the president of GB Consulting LLC, in Pennsylvania, since 2000 and provides regulatory compliance guidance and technical consulting services for pharmaceutical, biotechnology, and other FDA‑related industries. His experience includes supporting and leading teams for quality systems assessments, regulatory action responses and remediations (FDA483, Warning Letter, Consent Decree), and preparing sites to host regulatory inspections. He has developed and facilitated numerous highly interactive learning workshops worldwide, including Aseptic Training Programs, Batch Record Reviews, QA on the Floor, and aseptic training support for Compounding Centers. Before founding GB Consulting LLC, Graham gained extensive experience through various management positions in the pharmaceutical industry with SmithKline Beecham PLC (GlaxoSmithKline PLC), Wyeth Pharmaceuticals (Pfizer), and Astra Merck Inc. (AstraZeneca PLC). His career includes management responsibilities as a corporate compliance auditor, quality assurance, validation, and clinical trials manufacturing and packaging. Graham is the editor of Good Manufacturing Practices for Pharmaceuticals and Good Laboratory Practices for Non‑Clinical Studies and the author of several book chapters/journal articles. Graham earned a BSc in pharmacy from Brighton University, England, and an MSc in Quality Assurance and Regulatory Affairs from Temple University, Philadelphia, and is a member of the Regulatory Affairs Professional Society (RAPS).
