The integration of artificial intelligence through quality by digital design for sustainable pharmaceutical manufacturing

The pharmaceutical industry is increasingly embracing digital transformation to enhance product quality, manufacturing efficiency, and environmental sustainability. This review explores the integration of artificial intelligence (AI) within the quality by digital design (QbDD) framework, and its potential in representing an evolution of the traditional quality by design approach. Quality by digital design uses AI, machine learning, digital twins, and advanced data analytics to optimise drug development and manufacturing processes through real-time monitoring, predictive control, and continuous improvement. Key components such as design space, critical quality attributes, process analytical technology, and real-time release testing are redefined through digital tools, enabling proactive and adaptive process control. The role of AI in promoting sustainability is examined, with applications ranging from energy optimisation and waste reduction to predictive maintenance and supply chain efficiency. Real-world examples from leading pharmaceutical companies illustrate the practical benefits as well as the ongoing challenges of implementing QbDD. The review concludes by outlining future directions and opportunities for broader adoption, while highlighting the need for regulatory alignment, data integrity, and skilled workforce development to fully realise the potential of AI-enabled sustainable pharmaceutical manufacturing.