Overview

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

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9781032178387

Table of Contents

Reviews

I was very gratified with the overall format of this GMP Book. Concept is easy to read and follow. And tracked correctly. The purpose of this amazing book is very obliging. This book assures that all new and existing personnel will be able to understand their specific role. Highly recommended GMP book! Rosemarie Taruc, MQA Pharmaceutical

I was very gratified with the overall format of this GMP Book. Concept is easy to read and follow. And tracked correctly. The purpose of this amazing book is very obliging. This book assures that all new and existing personnel will be able to understand their specific role. Highly recommended GMP book! Rosemarie Taruc, MQA Pharmaceutical Brilliant ! The seventh edition of Good Manufacturing Practices for Pharmaceuticals is an invaluable resource for anyone in the pharmaceutical industry. It presents a clear and easy-to-understand guide that caters to both beginners and experienced professionals alike. The book effectively breaks down complex concepts, making them accessible to all readers. Additionally, it serves as an excellent reference for understanding regulations, particularly FDA expectations regarding CGMP and 21 CFR Part 210 & 211. Whether you’re new to the field or looking to refresh your knowledge, this book is a must-have for ensuring compliance and promoting best practices in manufacturing. It’s an excellent resource for all pharmaceutical companies to add to their curriculum. Cannot wait for the next edition. Juan P Calderon Pharmaceutical QA

Author Information

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.

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