Фармацевтическая аналитическая химия: открытый доступ
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Process Analytical Technology (PAT): Revolutionizing Pharmaceutical Manufacturing

Michael Leiss

Process Analytical Technology (PAT) has emerged as a pivotal tool in pharmaceutical manufacturing, revolutionizing the way drugs are produced and ensuring quality, safety, and efficiency throughout the manufacturing process. PAT encompasses a range of analytical techniques, including spectroscopy, chromatography, and chemo metrics, integrated into manufacturing processes to facilitate real-time monitoring, control, and optimization. This article explores the principles, applications, and benefits of PAT in pharmaceutical manufacturing. PAT is a systematic approach to pharmaceutical development, manufacturing, and quality assurance, endorsed by regulatory agencies like the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). It aims to enhance process understanding, facilitate continuous improvement, and ensure the quality of pharmaceutical products. PAT integrates advanced analytical technologies with process monitoring and control strategies to enable real-time measurement of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).