7th Edition

Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

Edited By Graham P. Bunn Copyright 2019
    385 Pages 50 B/W Illustrations
    by CRC Press

    385 Pages 50 B/W Illustrations
    by CRC Press

    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.

    Key Features:

    • Presents insight into the world of pharmaceutical quality systems
    • Analyzes regulatory trends and expectations
    • Includes approaches and practices used in the industry to comply with regulatory requirements
    • Discusses recent worldwide supply chain issues
    • Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry




    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



    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.