Issue link: https://www.e-digitaleditions.com/i/1517802
32 Pharmaceutical Technology ® Quality and Regulatory Sourcebook eBook March 2024 PharmTech.com Qualit y by Design non-contex t ua l i zat ion of key d at a. D u r i ng tech transfer, long discussions are often needed to agree on process and analy tical procedure recipe termi- nology across donor and receiver sites. Digital trans- formation involves improved new digital tools and business practices to enable efficient tech transfers. A new digital backbone, in the form of integrated data pipelines between digital systems within the CMC ecosystem (Figure 3), will enable faster f low of information across the tech transfer donor and re- ceiver sites. In addition, standardized business pro- cesses such as Enterprise Recipe Management (ERM) will ensure product and process information are de- scribed consistently across all sites and groups in- volved in tech transfer. The wider approach to ERM will enable multiple users to define the product, pro- cess, and analytical procedure characteristics in a structured framework within a digital ecosystem. Future integration of ERM with manufacturing exe- cution systems will open up many opportunities for automation and execution of the operational control strategy. Combined with the integration of digital QbD workf lows, such as the risk assessments as ex- plained in this article, this digital ecosystem will enable data (once defined) relating to the product control strateg y to be governed and monitored in 'real time' for tracking changes, as well as ensuring t he process and ana ly tica l procedure recipes are available to the end users as a single source of truth that evolves through development and the product lifec ycle. T h is w i l l enable t he digita l r isk assess- ments to be integrated with other key development data items such as material specifications, product characteristics, process design and equipment, qual- ity specifications, and master data management. A common data model including the elements above can be defined and subsequently leveraged to acceler- ate product development and transfer activities. Summary and conclusion This article explores the pivotal role of digitalization in QbD risk assessments within the pharmaceutical development and manufacturing processes. Digital QbD risk assessments provide significant benefits mov i ng f rom t rad it iona l spreadsheets a nd docu- ments to integrated, digital, database-driven sys- tems. There are other potential benefits to regula- tory and product lifecycle management, including improving the management of multiple versions of control strategies (13), ICH Q12 established condi- tions, and other market-specific registered detail. While the promised benefits of this digital strat- egy are clear, challenges associated with its tactical implementation should be acknowledged. First, a key requirement to realize the f ull set of benefits associated w it h a t r u ly t ra nscr ipt ion/check-f ree data f low is GxP validation of the platform(s). This has not yet been attempted by the authors; however, FIGURE 4. Example risk visualization outputs from iRISK (risk heat map and process risk mapping for "A-Mab" drug substance [DS] early-stage quality-by-design [QbD] risk assessment).