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12 BioPharm International ® Quality and Regulatory Sourcebook eBook March 2024 www.biopharminternational.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 expectations are met. A key pillar of QbD is quality risk management (QRM) (2), which posi- tions risk assessments at the intersection of numerous pharmaceutical processes, acting as a lynchpin, driving control strategy development, technology transfer (3,4), supporting regulatory submissions and lifecycle man- agement 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 identifying 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 quantify their criticality to craft effective risk mitigation and control strategies. Moreover, they help to prioritize the experimental strat- egy focusing on the process steps with a high number of critical parameters to establish the optimal modeling strategy. The overarching goal of a risk assessment is to provide decision-makers with a comprehensive un- derstanding of the drug product and manufacturing process, facilitating informed decision-making and the implementation of risk mitigation strategies. There are various risk management techniques described in International Council for Harmonisation (ICH) Q9, in- cluding basic risk management facilitation methods, failure mode and effects (criticality) analysis (FMEA and FMECA [2]), fault tree analysis (FTA), hazard anal- ysis and critical control points (HACCP), hazard opera- bility analysis (HAZOP), and preliminary hazard anal- ysis (PHA). FMEA, in particular, is a widely used tool for identifying, assessing, and analyzing risks used to prioritize work packages to ensure the development of safe and effective medicines. Digitalization of QbD Risk Assessments Gayathri Acharya, Matthew Pincus, Hervé Gressard, and Phil Borman all from GSK. The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem. PHOTON_PHOTO - STOCK.ADOBE.COM