FROM RISK TO QUALITY: QUALITY RISK MANAGEMENT IN PHARMA

Abstract

According to the International Council for Harmonization's (ICH) Q9 (R1) guideline, which goes into effect in May 2023, Quality Risk Management (QRM) offers a systematic and scientific method for controlling risks to the quality of pharmaceutical products at every stage of their lifetime. In order to increase uniformity within quality systems, the updated advice places a strong emphasis on risk-based decision-making, suitable formality levels, and the elimination of subjectivity. By helping pharmaceutical companies to recognize, evaluate, control, communicate, and analyse risks that might affect product safety, effectiveness, and compliance, QRM works closely with quality assurance. This study emphasizes the function of risk assessments in the production, distribution, and regulatory contexts of pharmaceuticals, showing how methodical assessment aids in avoiding quality failures and maximizing resource use. Numerous risk management techniques and instruments are covered, along with their usefulness, advantages, as well as restrictions. In order to improve proactive risk management, the study also examines implementation issues and new developments including digital technology, data analytics, and predictive methodologies.