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28 Pharmaceutical Technology ® Quality and Regulatory Sourcebook eBook March 2024 PharmTech.com Qualit y by Design One such digital QRM platform used to facilitate QbD risk assessments is iRISK (10), developed by Va lgenesis Inc. This web-based tool has been em- ployed by the authors for conducting QbD risk as- sessments and other QbD workf lows supporting the development and manufacture of small molecules, biologics, and vaccines. It has proved valuable as a tool in enabling the development of robust drug sub- stance and drug product control strategies across multiple products. The use of iRISK has resulted in numerous benefits and the authors anticipate that this digital risk assessment platform will become an integral par t of a much broader product devel- opment digital ecosystem. Drivers for QbD risk assessment digitalization A powerful digital risk assessment platform (a single QbD tool) can enhance data interoperability (estab- lishing links between product, process, and analyti- cal understanding), advanced analytics, and knowl- edge transfer, enabling cross-functional learning and highly informed decision making. Digital transfor- mation of risk assessments can reduce the time and human errors possible from traditional risk manage- ment, technology transfer, and reporting. A generalized QbD data f low for an example bio- pharmaceutical product using standard non-digi- talized, unintegrated tools is presented in Figure 2. Prior knowledge and process development data may be stored in databases linked to laboratory systems and/or published as individual analyses and reports. The information from these sources' feeds directly into the product and process definition, which can include process tech transfer (process description) documents, bill of materials, and the quality target product profile (QTPP, which may also include a list of critical qualit y attributes [CQAs]). The product and process definition (i.e., product attributes and process recipe) acts as the defining input for several QbD risk assessments, including a CQA risk assess- ment (wh ich in t ur n produces a CQA document), va r ious process r isk assessments, a nd raw mate- rial risk assessments. Additional contextualizing platform knowledge and process development data sources are also leveraged to guide the execution of these risk assessments. The main outputs of these r isk assessments—of ten sum ma r ized at specif ic timepoints in individually published reports—are m ater i a l, pa ra meter, a nd at t r ibute c r it ica l it ies, along with critical process controls and information FIGURE 2. Legacy "paper-based" quality-by-design (QbD) data flow (generalized for an example biopharm product and simplified to a single lifecycle iteration).