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).

• Preface. Contributors. About The Editor. Chapter 1: Status and Applicability of U.S. Regulations: CGMP. Chapter 2: Quality Management Systems and Risk Management. Chapter 3: Management Responsibility and Control. Chapter 4: Organization and Personnel. Chapter 5: Finished Pharmaceuticals: General Provisions. Chapter 6: Production and Process Controls. Chapter 7: Records and Reports. Chapter 8: Clinical Trial Supplies. Chapter 9: Contracting and Outsourcing. Chapter 10: Buildings and Facilities. Chapter 11: Equipment. Chapter 12: Control of Components and Drug Product Containers and Closures. Chapter 13: Holding and Distribution. Chapter 14: Returned and Salvaged Drug Products. Chapter 15: Active Pharmaceutical Ingredients. Chapter 16: Pharmaceutical Excipient Good Manufacturing Practices. Chapter 17: Packaging and Labeling Control. Chapter 18: Laboratory Controls. Chapter 19: FDA Inspections of 503A Compounding Pharmacies and 503B Outsourcing Facilities. Chapter 20: CGMP Enforcement Alternatives in the United States. Chapter 21: FDA Inspection Process. Chapter 22: FDA Pre-approval Inspections. Chapter 23: Best Practices for the Pharmaceutical Industry: FDA Guidance on Refusing an Inspection. Chapter 24: The Qualified Person in the Pharmaceutical Industry. Chapter 25: Data Integrity and Fundamental Responsibilities. Index

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).

• Preface. Contributors. About The Editor. Chapter 1: Status and Applicability of U.S. Regulations: CGMP. Chapter 2: Quality Management Systems and Risk Management. Chapter 3: Management Responsibility and Control. Chapter 4: Organization and Personnel. Chapter 5: Finished Pharmaceuticals: General Provisions. Chapter 6: Production and Process Controls. Chapter 7: Records and Reports. Chapter 8: Clinical Trial Supplies. Chapter 9: Contracting and Outsourcing. Chapter 10: Buildings and Facilities. Chapter 11: Equipment. Chapter 12: Control of Components and Drug Product Containers and Closures. Chapter 13: Holding and Distribution. Chapter 14: Returned and Salvaged Drug Products. Chapter 15: Active Pharmaceutical Ingredients. Chapter 16: Pharmaceutical Excipient Good Manufacturing Practices. Chapter 17: Packaging and Labeling Control. Chapter 18: Laboratory Controls. Chapter 19: FDA Inspections of 503A Compounding Pharmacies and 503B Outsourcing Facilities. Chapter 20: CGMP Enforcement Alternatives in the United States. Chapter 21: FDA Inspection Process. Chapter 22: FDA Pre-approval Inspections. Chapter 23: Best Practices for the Pharmaceutical Industry: FDA Guidance on Refusing an Inspection. Chapter 24: The Qualified Person in the Pharmaceutical Industry. Chapter 25: Data Integrity and Fundamental Responsibilities. Index

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).

• Preface. Contributors. About The Editor. Chapter 1: Status and Applicability of U.S. Regulations: CGMP. Chapter 2: Quality Management Systems and Risk Management. Chapter 3: Management Responsibility and Control. Chapter 4: Organization and Personnel. Chapter 5: Finished Pharmaceuticals: General Provisions. Chapter 6: Production and Process Controls. Chapter 7: Records and Reports. Chapter 8: Clinical Trial Supplies. Chapter 9: Contracting and Outsourcing. Chapter 10: Buildings and Facilities. Chapter 11: Equipment. Chapter 12: Control of Components and Drug Product Containers and Closures. Chapter 13: Holding and Distribution. Chapter 14: Returned and Salvaged Drug Products. Chapter 15: Active Pharmaceutical Ingredients. Chapter 16: Pharmaceutical Excipient Good Manufacturing Practices. Chapter 17: Packaging and Labeling Control. Chapter 18: Laboratory Controls. Chapter 19: FDA Inspections of 503A Compounding Pharmacies and 503B Outsourcing Facilities. Chapter 20: CGMP Enforcement Alternatives in the United States. Chapter 21: FDA Inspection Process. Chapter 22: FDA Pre-approval Inspections. Chapter 23: Best Practices for the Pharmaceutical Industry: FDA Guidance on Refusing an Inspection. Chapter 24: The Qualified Person in the Pharmaceutical Industry. Chapter 25: Data Integrity and Fundamental Responsibilities. Index