Steps Towards Demystifying Risk-Based Decision Making: It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

The article focuses on demystifying risk-based decision making (RBDM) in pharmaceutical quality systems, especially in the context of the ICH Q9(R1) guidelines. Topics include the differences between RBDM and other decision-making processes; the importance of RBDM in enhancing quality risk management (QRM) effectiveness for patient benefit; and recommendations for improving RBDM like deciding the appropriate level of formality and providing the best available knowledge.