Issue link: https://www.e-digitaleditions.com/i/1517802
26 Pharmaceutical Technology ® Quality and Regulatory Sourcebook eBook March 2024 PharmTech.com photon_photo - Stock.adobe.com T he use of quality-by-design (QbD) principles (1), supported by standard processes and tools, are well established across industry for delivering enhanced understanding of pharmaceutical drug product and manufacturing processes as well as ensuring regulatory expec- tations are met. A key pillar of QbD is quality risk management (QRM) (2), which positions risk assess- ments at the intersection of numerous pharmaceu- tical processes, acting as a lynchpin, driving control strategy development, technology transfer (3,4), supporting regulatory submissions and lifecy- cle management of manufacturing processes (5). The primary objective of this article is to explore the use of digital risk assessment platforms and their advantages. Risk assessments are an essential element within the QbD framework and play a vital role in identify- ing and controlling product quality risks across the product life cycle. Risk assessments systematically dissect both product and process designs based on potential hazards, aiming to identify risks and quan- tify their criticality to craft effective risk mitigation and control strategies. Moreover, they help to pri- oritize the experimental strateg y focusing on the process steps with a high number of critical parame- ters to establish the optimal modeling strategy. The overarching goal of a risk assessment is to provide decision-makers with a comprehensive understand- ing of the drug product and manufacturing process, facilitating informed decision-making and the im- plementation of risk mitigation strategies. There are various risk management techniques described in In- ternational Council for Harmonisation (ICH) Q9, in- cluding basic risk management facilitation methods, failure mode and effects (criticality) analysis (FMEA Digitalization of QbD Risk Assessments Gayathri Acharya, Matthew Pincus, Hervé Gressard, and Phil Borman Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.