Linking Risk Management to Batch Release, QP/RP Decisions and QMS Metrics The integration of Risk Management in pharmaceutical operations is essential for compliance with FDA regulations and enhancing product quality. Quality Risk Management (QRM) is not just a regulatory requirement but a fundamental aspect of a Quality Management System (QMS) that governs batch release, Qualified Person (QP)/Responsible Person (RP) decisions, and relevant metrics. This article aims to provide a comprehensive step-by-step tutorial on aligning these elements effectively. Step 1: Understanding Quality Risk Management and FDA Expectations Quality Risk Management is defined in ICH Q9 as a systematic process for identifying,…