A REVIEW ON APPLICATION OF PROCESS ANALYTICAL TECHNOLOGY (PAT)
Kalyan G. Wagh, Dr.Swati S.Rawat, Dr. Sunil S. Jaybhaye, Mr. Yogiraj P. Muley, Mr. Saurabh M. Bondre
Institute of Pharmacy, Badnapur, Dist. Jalna, Maharashtra
Abstract
The initiative titled “Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century—A Risk-Based Approach,” launched by the FDA in August 2002, aimed to modernize and improve pharmaceutical manufacturing processes, encouraging the adoption of Process Analytical Technology (PAT) within the industry. PAT offers significant potential for enhanced operational control and regulatory compliance through continuous real-time quality assurance. Over the past decade, extensive research and development have been conducted by both academic and industrial contributors on this subject. This paper begins with a concise overview of the evolution of PAT concepts and explores their broader application within the pharmaceutical industry. The focus then shifts to PAT applications in biotech processes, with particular attention to developments over the last five years. While there has been substantial progress in the ability to analyze and monitor critical process and quality attributes in the biotech industry, further advancements are needed in utilizing this data for process control, optimizing yield, and ensuring product quality. Achieving these outcomes is essential to fully realize the benefits of PAT implementation.
Keywords: Process Analytical Technology (PAT), PAT Goals, PAT Framework, What is PAT, PAT Application In Chemical Industries, PAT Application In The Pharmaceutical Industry, PAT Appllication In The Biotechnology Industry.
Journal Name :
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EPRA International Journal of Research & Development (IJRD)
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Published on : 2024-11-23
Vol | : | 9 |
Issue | : | 11 |
Month | : | November |
Year | : | 2024 |