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34 Pharmaceutical Technology ® Quality and Regulatory Sourcebook eBook March 2024 PharmTech.com Qualit y by Design many commercial off-the-shelf systems for digital produc t prof i le, enter pr i se recipe m a n agement, product lifecycle management, and QbD risk man- agement (i.e., iRISK) are designed to be compliant wit h FDA, European Union Good Manufact uring P rac t ice A n nex 15, Eu ropea n Med ici nes Agenc y, and ICH guidelines. A related challenge is the ini- tial establishment of a common data standard and data model across different technical stakeholder groups and digital platforms. As explored above, the use of a digital risk assessment platform, along with related ERM and digita l product prof i le tools, re- quire and enable the governance of data standards. Lastly, the shift to conducting risk assessments, and indeed the whole of process development and lifecy- cle management, in a fully digital format requires deliberate change management of people and orga- nizations. Here, improvement of digital f luency can accelerate movement along the 'change curve'. In summary, the development and integration of a digital risk assessment platform into a wider digital ecosystem, encompassing QbD and product devel- opment processes, such as ERM and Manufacturing Execution Systems, are means to expedite the over- all drug development process. This article is aimed at ser ving as an exploration of the transformative potential of a digital risk assessment platform in reshaping pharmaceutical development processes and improving regulatory compliance. References 1. ICH. ICH Q8(R2) Pharmaceutical Development. Step 4 Version (August, 2009). 2. ICH. ICH Q 9(R1) Qualit y Risk Management. Final Version (January, 2023). 3. ICH. ICH Q10 Pharmaceutical Quality System. Step 4 Version (June, 2008). 4. ISPE. Good Practice Guide: Technology Transfer. Third Edition, ISPE, Jan. 1, 2018. 5. ICH. ICH Q12 Technical and Regulator y Consider- ations for Pharmaceutical Product Lifecycle Manage- ment. Final Version (November, 2019). 6. Yu, L. X.; Raw, A.; Wu, L.; Capacci-Daniel, C.; Zhang, Y.; Rosencra nce, S. FDA's New Pha r maceut ica l Quality Initiative: Knowledge-Aided Assessment & Structured Applications. Int. J. Pharm.: X 2019, 1, 100010. DOI: 10.1016/j.ijpx.2019.100010. 7. European Commission. Guidelines on Good Man- ufact uring Practice Specif ic to Advanced Ther- apy Medicinal Products. EudraLex Volume 4, Nov. 22, 2017. ht t ps:// hea lt h.ec.eu ropa.eu/s ystem/ f i les/2017-11/2017_11 _22 _ g uidel i nes_ gmp _for_ atmps_0.pdf 8. EFPIA. EFPIA White Paper on CMC Development, Manufacture and Supply of Pandemic COVID-19 Therapies and Vaccine. EFPIA.eu, June 8, 2020. 9. ICH. ICH Q14 Analytical P rocedure De velopment. Final Version (November, 2023). 10. Valgenesis. iRISK. https://w w w.valgenesis.com/ product/valgenesis-irisk (accessed March 5, 2024). 11. Borman, P.; Chatfield, M.; Nethercote, P.; Thomp- son, D.; Truman, K. The Application of Quality by Design to Analytical Methods. Pharm. Tech. 2007, 31 (12), 142–152. 12. ICH. T he Common Technical Document for the Reg- istration of Pharmaceuticals for Human Use: Qual- ity—M4Q(R1), Quality Overall Summary of Module 2, Module 3: Quality. Step 4 Version (September, 2002). 13. Beierle, J.; Cauchon, N.; Graul, T.; et al. Toward a Single Global Control Strateg y: Industr y Study. Pharm. Eng. 2022, 42 (1), 20–31. 14. Popkin, M.E.; Borman, P.J.; Omer, B.A.; et al. The Delivery of Flexibility from the Application of QbD to API Development. J. Pharm. Innov. 2018, 13 (4), 367–372,. DOI: 10.1007/s12247-018-9339-8. 15. Jackson, P.; Borman, P.; Campa, C.; et al. Using the Analytical Target Profile to Drive the Analytical Method Lifecycle. Anal. Chem. 2019, 91 (4), 2577– 2585. DOI: 10.1021/acs.analchem.8b04596. 16. Borman, P.; Campa, C.; Delpierre, G.; et al. Selection of Analytical Technology and Development of Ana- lytical Procedures Using the Analytical Target Pro- file. Anal. Chem. 2022, 94 (2), 559–570. DOI: 10.1021/ acs.analchem.1c03854 Scopus. 17. Popkin, M.E.; Borman, P.J.; Omer, B.A.; Looker, A.; Kallemeyn, J.M. Enhanced Approaches to the Iden- tification, Evaluation, and Control of Impurities. J. Pharm. Innov. 2019, 14 (2), 176–184. DOI: 10.1007/ s12247-018-9363-8. ■ 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*, phil.j.borman@gsk.com, is director and senior fellow, QbD and digital platforms, medicines development and supply at GSK, Stevenage, UK. *To whom all correspondence should be addressed