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.

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