ICH Q9 and Regulatory Risk Frameworks in Validation: Expectations, Tools & Implementation ICH Q9 and Risk Frameworks in Pharma Validation: Regulatory Expectations, Tools & Implementation Quality Risk Management (QRM) is a core component of pharmaceutical compliance — embedded in GMP principles, regulatory guidelines, and validation activities across the product lifecycle. With the revision of ICH Q9 in 2023 and increasing FDA emphasis on risk-based decision-making, it is now essential for validation teams to integrate risk frameworks seamlessly into protocols, plans, and quality systems. This guide offers a comprehensive breakdown of QRM expectations in validation, with detailed implementation strategies for equipment…