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.
- Utilizes explicit case studies to illustrate ideas throughout the content
- Emphasizes three key areas, including management, supervisors and staff
- Written by a leader in the field with experience in regulatory, research and technical areas
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
Dr. Hussain worked as an academic at Ohio Northern University and the University of Cincinnati progressing to a tenured associate professor. In 1995, Dr. Hussain moved to the US Food and Drug Administration (FDA) where he served in various positions before becoming deputy director of its Office of Pharmaceutical Studies in 2000. He also held a Senior Biomedical Research Scientist position. He is widely recognized for his leadership of several FDA initiatives such as Process Analytical Technology and Pharmaceutical Quality for the 21st Century. Following a ten-year career at FDA, Dr. Hussain served as Vice President and Global Head of Biopharmaceutical Development at Sandoz AG where he was responsible for development and regulatory submissions of biosimilars, follow-on proteins, and complex generic products. He also served as Vice President Next Generation Product Assessment and then as Chief Scientific Officer at Philip Morris International in Switzerland developing strategies and systems for advancing development programs on plant-based vaccines and products for tobacco harm reduction. In 2012-2013, Dr. Hussain became President Biotechnology and Chief Scientific Office at Wockhardt Ltd before founding his own consulting company, Insight, Advice and Solutions, LLC, in July 2013. He is a Fellow of the American Association of Pharmaceutical Scientists and of the Swiss Society for Pharmaceutical Sciences and recipient of several FDA and professional association awards. He has co-authored numerous scientific publications in the area of pharmaceutical science and holds several visiting professorships.