This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change task-oriented cultures to integrated quality business systems. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics.
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 Good Manufacturing Practices in the industry.
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 FDArelated 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 NonClinical 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).
