Issue link: https://www.e-digitaleditions.com/i/1517802
PharmTech.com Quality and Regulatory Sourcebook eBook March 2024 Pharmaceutical Technology ® 31 Qualit y by Design process design selections, identif ication of CQAs, and summaries of parametric and attribute control all have elements that can be digitalized and inte- grated with risk assessments, because they leverage a common digital product profile (a digitalized mas- ter version of product and process definition details, including process recipes, parameter and attribute information, and key control strategy information). Beierle et al. (13) highlight the challenges associ- ated with the lack of global regulator y harmoniza- tion of control strategies which present a hindrance to the acceleration of innovative therapeutics for m i l l ions of pat ients a round t he globe for un met medical needs. Additionally, the abilit y to contin- ually improve the pharmaceutical manufacturing process (14) and analytical procedures (15–17) can be impeded by regulatory authorities adopting differ- ent approaches for assessing post-approval changes. While driving towards a global harmonized regula- tor y control strateg y is aspirational and desirable, different approved versions of the control strategy across multiple reg ulator y regions wi l l continue to be a challenge for pharmaceutical companies to manage across the lifecycle for the foreseeable f u- ture. The use of digital risk assessments via tools like iRISK provides new opportunities for managing these often subtly different approved control strate- gies across different regulatory regions in a more ef- fective manner. As industry adopts the Q12 concept of identifying ECs, tools like iRISK can be leveraged to manage possible additional regional differences. Benefits for technology transfer Across produc t a nd process development, i n for- mation is generated and transferred between R&D and manufact uring in standard data forms and/ or across d i s pa rate s ys tem s. T h i s lead s to h ig h data search times followed by inconsistencies and FIGURE 3. Enhanced digital quality-by-design (QbD) data flow and digital chemistry, manufacturing, and controls (CMC) ecosystem (simplified).