Abstract

QUALITY RISK MANAGEMENT IN PHARMACEUTICAL INDUSTRY

*Tejas Patil

ABSTRACT

Quality Risk Management (QRM) is a systematic, science-based approach for the assessment, control, communication, and review of risks affecting pharmaceutical quality and patient safety. Introduced through the International Council for Harmonisation (ICH) guideline Q9, QRM has become an essential component of pharmaceutical development, manufacturing, and regulatory compliance. This literature review discusses the principles, regulatory framework, methodologies, tools, and applications of QRM in the pharmaceutical industry. It also highlights its integration into Quality by Design (QbD), Good Manufacturing Practices (GMP), and lifecycle management of drug products. Emerging trends such as digitalization, artificial intelligence, and continuous manufacturing in risk-based decision-making are also discussed.

Keywords: Quality Risk Management, ICH Q9, Risk Assessment, FMEA, GMP, Pharmaceutical Quality, QbD.