International Journal on Science and Technology

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The Impact of Artificial Intelligence (AI) on Novel Formulations Development and Quality Risk Management of Pharmaceutical Products

Author(s) Bane Singh Rajput, Girdhar Khandelwal, Nikki Tripathi
Country India
Abstract Artificial Intelligence (AI) has emerged as a transformative force in the pharmaceutical industry, significantly influencing drug discovery, formulation development, manufacturing, and quality assurance. This research paper explores the role of AI in enhancing novel formulation development and strengthening quality risk management (QRM) systems in pharmaceutical products. AI-driven tools such as machine learning (ML), deep learning (DL), and predictive analytics enable data-driven decision-making, reduce development timelines, and improve product quality. In formulation development, AI assists in predicting physicochemical properties, optimizing excipient selection, and modeling drug release kinetics, thereby minimizing trial-and-error experimentation. Additionally, AI enhances Quality by Design (QbD) approaches by identifying critical quality attributes (CQAs) and process parameters. In the context of quality risk management, AI facilitates predictive risk analysis, real-time monitoring, deviation detection, and regulatory compliance. The integration of AI in pharmaceutical processes leads to improved efficiency, reduced costs, enhanced patient safety, and proactive risk mitigation. However, challenges such as data availability, model interpretability, regulatory acceptance, and ethical concerns persist. This paper reviews current literature, outlines methodologies, analyzes results, and discusses future directions for AI integration in pharmaceutical sciences. The findings suggest that AI will play a pivotal role in shaping next-generation pharmaceutical development and quality systems.
Keywords .
Field Medical / Pharmacy
Published In Volume 17, Issue 1, January-March 2026
Published On 2026-03-31
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