Vyawhare , N. A. . “An FMEA-Driven Holistic Approach to Quality Risk Management for New Product Introduction in Pharmaceutical Commercial Plant: Navigating Global Regulatory Landscapes”. International Journal of Research in Pharmaceutical Sciences, vol. 16, no. 3, Aug. 2025, pp. 24-45, doi:10.26452/ijrps.v16i3.4788.