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Global Academic Journal of Pharmacy and Drug Research
Volume-8 | Issue-03
Original Research Article
Process Analytical Technology (PAT)-Enabled Real-Time Release Testing (RTRT) for Oral Solid Dosage Forms: Replacing End-of-Batch Testing in Continuous Manufacturing
Asharaf Yunusbhai Kalaniya
Published : May 5, 2026
DOI : https://doi.org/10.36348/gajpdr.2026.v08i03.001
Abstract
Traditional end-of-batch release testing in pharmaceutical manufacturing is a retrospective, time-consuming, and resource-intensive quality assurance model that detects failures after they occur rather than preventing them during production. The advent of continuous manufacturing (CM) for Oral Solid Dosage (OSD) forms, combined with advances in Process Analytical Technology (PAT), has created a compelling scientific and regulatory opportunity to replace conventional offline laboratory testing with Real-Time Release Testing (RTRT) — a paradigm in which product quality is continuously verified during manufacturing using validated in-line and online analytical measurements. RTRT is formally supported by ICH Q8(R2), the FDA PAT Guidance (2004), and EMA RTRT guidelines, representing the highest tier of pharmaceutical quality assurance achievable within a QbD-compliant continuous manufacturing environment [8–10].

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