Chemistry, manufacturing and controls

​HM6: How Artificial Intelligence is transforming regulatory approaches towards chemistry, manufacturing and controls (CMC)

By 2025-11-13T14:35:00

Mónica Perea-Vélez

Key points: 

  • Quality by Digital Design (QbDD): Manufacturing is shifting from traditional Quality by Design (QbD) to QbDD, a new paradigm embedding quality, process models, sustainability and manufacturability from the earliest stages of development 
  • Regulatory support: The European Medicines Agency (EMA) prioritises innovation and advanced manufacturing through its Quality Innovation Group (QIG), which provides tailored scientific advice and fosters global regulatory convergence 

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