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