1. Introduction: From Reactive to Proactive Quality In the high-stakes environment of sterile injectables, waiting for a failure to occur is not an option. Quality Risk Management (QRM) is the systematic, proactive process of assessing, controlling, communicating, and reviewing risks to product quality. Drawing from my 11+ years of experience navigating USFDA and MHRA audits. I have seen that a robust, scientifically sound QRM program is the fundamental difference between a minor observation and a severe Warning Letter. 2. The Regulatory Bedrock: Understanding ICH Q9(R1) The International Council for Harmonisation (ICH) provides the global standard through the Q9 guideline. The recent revision, ICH Q9(R1) , emphasizes reducing subjectivity and ensuring a scientific basis for risk assessments. Patient Protection: The core purpose of QRM is to safeguard the patient; all evaluations must link back to patient health. Proportionality: The level of effort and doc...
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