Digitalization of QbD Risk Assessments

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BioPharm International, Quality and Regulatory Sourcebook, March 2024 eBook, Volume 2024 eBook, Issue 1
Pages: 26–34

The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

The use of quality-by-design (QbD) principles, 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), which positions risk assessments at the intersection of numerous pharmaceutical processes, acting as a lynchpin, driving control strategy development, technology transfer, supporting regulatory submissions and lifecycle management of manufacturing processes. 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 strategy 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 understanding 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, including basic risk management facilitation methods, failure mode and effects (criticality) analysis (FMEA and FMECA), fault tree analysis (FTA), hazard analysis and critical control points (HACCP), hazard operability analysis (HAZOP), and preliminary hazard analysis (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.

Traditional risk assessment workflows using spreadsheets or word-processors can be laborious and have limited capacity to connect with the vast volumes of data generated by organizations, including product specific understanding. This leads to challenges with leveraging prior knowledge, which in turn can result in unwanted inconsistencies between risk assessments for a single product or across multiple products of the same modality. While these risk assessments are acknowledged for their inherent value, they are limited in scalability and susceptible to human errors. The resource-intensive nature of these assessments results in the generation of large datasets that prove complex to maintain and analyze using traditional techniques, leading to knowledge silos.


In response to the evolving landscape, pharmaceutical companies have developed risk assessments embedded with prior knowledge, often stored in a collection of spreadsheets and written report templates. However, these encounter the same challenges that extend beyond their effectiveness, posing limitations on knowledge sharing. The current paradigm of risk assessments operating primarily in this traditional, siloed, unintegrated format results in significant challenges associated with collaborative risk management across disciplines, groups, and even regulatory agencies, making the need for a more integrated and collaborative digital approach evident.

Read this article in the BioPharm International® Quality and Regulatory Sourcebook eBook.

About the authors

Gayathri Acharya is scientific leader, QbD and digital platforms, medicines development and supply at GSK Upper Providence, Collegeville, PA, USA.
Matthew Pincus is scientific leader, QbD and digital platforms, medicines development and supply at GSK Upper Merion, King of Prussia, PA, USA.
Hervé Gressard is head vaccines projects CMC statistics technical R&D, Projects, and Digital Sciences at GSK, Rixensart, Belgium.
Phil Borman*,, is director and senior fellow, QbD and digital platforms, medicines development and supply at GSK, Stevenage, UK.
*To whom all correspondence should be addressed.

Article details

BioPharm International
eBook: Quality and Regulatory Sourcebook 2024
March 2024
Pages: 12–18


When referring to this article, please cite it as Borman, P. Digitalization of QbD Risk Assessments. BioPharm International® Quality and Regulatory Sourcebook eBook (March 2024).