There is a consistent theme that comes up in the world of pharmaceutical process development and validation: a pervasive confusion around how ICH guidelines match up with quality-by-design principles and how they come together to enable the requirements of Pharma 4.0 to develop a holistic production control strategy.
The confusion is not necessary because there is considerable overlap between all of these principles. In this video, you can listen to our QbD Specialist, Sana Ahmed M.Sc., as she describes how these concepts are aligned and examples of how they can be implemented for your process development and validation activities.
Of course, the larger challenge is the lack of digital platforms to manage these activities and to ensure the integrity of the associated streams of data.
QbDVision solves this problem by providing a structured data repository aligned with the principles and milestones of ICH and QbD simplifying compliance with the knowledge and quality risk management requirements that serve as a bridge from process understanding to robust process control.