In pharmaceutical R&D and manufacturing, an AI model is a computational system trained on large datasets (e.g., genomic, chemical, or operational manufacturing data) to identify patterns, make predictions, and automate decision-making. These models, including deep learning and machine learning algorithms, are central to Pharma 4.0 initiatives. Applications span AI-assisted drug design, optimizing cGMP processes, predicting equipment failure (predictive maintenance), and enhancing supply chain resilience. For high-stakes applications, models must be validated and governed to ensure compliance with regulatory expectations for transparency and reliability.