Quality Culture in the Pharmaceutical Industry: Implementing a Behavior-based Quality and Compliance Culture

More about the book

Many pharmaceutical companies struggle to meet GMP and regulatory requirements because they focus on fixing symptoms rather than addressing the root cause: a weak quality and compliance culture. This book aims to provide leaders and senior managers with a roadmap to resolve regulatory issues and foster a robust quality culture. The key elements for success include having capable people (especially leaders), effective procedures, and comprehensive training programs that promote a positive culture of quality and compliance. By adopting a behavior-based approach, companies can view their challenges holistically, recognizing the multiple factors, including personal and organizational behaviors, that influence performance. A beneficial outcome of this systemic thinking is the transition from primarily corrective CAPA programs to those emphasizing systemic preventive actions. While quality is a shared responsibility, the creation and maintenance of a strong culture rests with leaders and senior managers. The good news is that establishing a sustainable quality culture is achievable, albeit challenging. This book outlines ten foundational principles for cultivating a strong quality culture, detailing desired behaviors and leading indicators to monitor and enhance leadership and people engagement, as well as cultural maturity.