Is Risk-Based Quality Management the Future of Pharmaceutical Manufacturing?

Abstract

Risk-Based Quality Management (RBQM) has emerged as a vital framework in pharmaceutical manufacturing and clinical trials, promoting proactive risk assessment to improve product quality and patient safety. Unlike traditional compliance-based quality management, RBQM integrates risk assessment, control, continuous monitoring, and transparent communication throughout the product lifecycle. This shift has enabled the pharmaceutical industry to enhance operational efficiency, reduce costs, and better meet regulatory expectations. The adoption of RBQM aligns with guidelines from bodies such as the International Council for Harmonisation (ICH) and regulatory agencies like the FDA and EMA, which emphasize quality through science-based decision-making. However, implementing RBQM poses challenges, including regulatory compliance complexities and the need for specialized training and technological infrastructure. Case studies illustrate successful RBQM implementations where data analytics, AI, and digital tools have been used to monitor quality risks and support real-time interventions. This review highlights the advantages, challenges, and future outlook of RBQM, underscoring its potential to shape pharmaceutical quality management and foster innovation.