How to Build and Maintain an Effective Pharmaceutical Quality Management System shares unique insights on how to improve our understanding of human factors in pharmaceutical quality. It describes practical ways to improve systems thinking and ways to establish effective quality management systems. Insights are derived from the author's experience at the US Federal Drug Administration (FDA) and as a leader of the FDA's PAT and 21st Century Initiatives, and finally, as an industry executive. The book describes the fundamental concepts and explains how to understand QMS, particularly focusing on the essential role of human factors that are illustrated through real-life examples.
Table of Contents
Section I: Why is pharmaceutical quality assurance prone to frequent failures?1. Introduction to pharmaceutical quality in the context of therapeutic outcomes
2. Pharmaceutical quality failures in the 20th century
3. Progress and challenges in moving towards the desired state of pharmaceutical quality in the 21st century
4. Human factors, biases, and blind-spots and science and technology gaps
Section II: What is the 21st Century Pharmaceutical Quality?
5. A new, higher, level of quality assurance
6. 21st pharmaceutical quality, 21st Cures Act & Manufacturing USA
7. Case Example: QMS Considerations for successful launch of a complex generic product
Section III: How to build and maintain an effective Pharmaceutical QMS
8. Remediating an existing QMS: After negative regulatory outcome
9. Effectiveness Assessment of an Existing QMS: Preventing a negative regulatory outcome
10. Ceasing dependence on external regulators: Culture of Quality
