• Dr Shruti Srivastava
• Dr Uma Shanker Maurya
• Mr. Ramesh Mapari

Real-Time Release Testing (RTRT) is an advanced approach in pharmaceutical manufacturing that enables the real-time assessment of a product’s quality during production, bypassing the need for traditional end-product testing. RTRT relies on continuous monitoring and control of critical quality attributes (CQAs) throughout the manufacturing process. This leads to faster decision-making and improved product quality assurance. The integration of Process Analytical Technology (PAT) into RTRT is fundamental to its success. PAT involves using advanced analytical tools and techniques to monitor and control the critical process parameters (CPPs) that influence CQAs. Techniques like near-infrared spectroscopy (NIR), Raman spectroscopy, and multivariate data analysis (MVDA) are commonly employed. These real-time measurements ensure that the process stays within predefined specifications, allowing for immediate adjustments if needed. By incorporating PAT into RTRT, pharmaceutical companies can achieve more efficient, cost-effective manufacturing processes. This approach minimizes production cycle times, reduces waste, and improves compliance with regulatory standards. Moreover, RTRT with PAT helps enhance product consistency, patient safety, and overall process robustness, aligning with the broader goals of Quality by Design (QbD). Thus, Real-time RTRT and PAT are innovative approaches in pharmaceutical manufacturing aimed at ensuring product quality and efficiency. Despite their potential, several challenges hinder their widespread implementation

Analytical, Critical process parameters, Quality by design, Spectroscopy

"Real-Time Release Testing With Process Analytical Technology In Pharmaceuticals", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 3, page no.e450-e457, March-2025, Available :http://www.jetir.org/papers/JETIR2503465.pdf

"Real-Time Release Testing With Process Analytical Technology In Pharmaceuticals", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 3, page no. ppe450-e457, March-2025, Available at : http://www.jetir.org/papers/JETIR2503465.pdf