Quality by Design in Public Healthcare: A Rapid Development Framework for Future Pandemics

Abstract

The growing number of pandemics and emergencies traversing the world in recent decades has illustrated the vulnerability of the conventional pharmaceutical development process and the necessity of an efficient, robust, and patient-driven pandemic-ready development model. QbD is a scientifically proven proactive approach that has been comprehensively examined recently for its potential to effectively optimize formulations in an accelerated time frame. Risk factor assessment and constant surveillance serve to maintain the product quality & standards before the final stage of large-scale production and offer regulatory pliability. The extension of this method, AQbD, paired side by side also assists in accelerated assessment and quality assurance which is a critical component in any global circumstance. In recent years studies have been done by applying this novel approach, but very little has been reported on the establishment of this approach as a Pandemic-Ready Development Framework. This mini review addresses the regulatory basis alongside the key principles of QbD, which aligns its working approach as optimally compatible with any pandemic situation. Furthermore, it emphasizes the widespread implementation of this approach as AQbD, which stands for swift testing coupled with quality assurance standards. It also focuses on the limitations and critical areas where QbD can be applied to cope with existing demands in near future. Further, it applies this approach in several formulation developments pertinent to pandemic or endemic conditions and discusses the challenges of implementation and future directions. Overall, this discussion stresses the potential of this approach as a very promising framework for future pandemics.