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.
