Transforming pharmaceutical quality assurance and validation through artificial intelligence

The evolution of artificial intelligence (AI) in the pharmaceutical industry spans from its early applications in automating administrative tasks to its pivotal role in drug discovery, personalized medicine, and safety enhancement. AI contributes significantly to data analysis, real-time process monitoring, defect detection, predictive maintenance, and compliance assurance, thereby enhancing efficiency, accuracy, and regulatory adherence. This review assesses the transformative functions of AI integration in revolutionizing quality assurance and validation across the pharmaceutical industry and highlights the contribution of AI in advancing quality frameworks, core values, and smart manufacturing. Moreover, the role of AI in enhancing validation processes and the critical importance of data and algorithms are discussed. As AI continues to reshape the pharmaceutical industry, it emphasizes the synergy between technological innovation and quality enhancement.