ICH Q9 (Quality Risk Management)

ICH Q9 (Quality Risk Management) is a guideline that helps organizations systematically identify, evaluate, and control potential risks to product quality. It involves assessing factors like manufacturing processes, raw materials, and storage to prevent issues before they happen. The goal is to ensure medicines are safe, effective, and consistently meeting quality standards while making efficient use of resources. By applying structured risk management principles, companies can prioritize actions based on risk levels, making informed decisions to protect patients and maintain compliance with regulations.