ABSTRACT
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
