Applying FMEA to Equipment, Process & Cleaning Validation in Pharma How to Apply FMEA to Equipment, Process & Cleaning Validation in Pharma In the pharmaceutical industry, implementing Failure Mode and Effects Analysis (FMEA) in validation activities enhances control, traceability, and risk mitigation. With rising expectations from FDA, EMA, and global regulators under ICH Q9, integrating FMEA into validation protocols is no longer optional — it’s a regulatory necessity. This article offers a step-by-step approach to applying FMEA in three critical validation areas: equipment qualification, process validation, and cleaning validation. It includes sample RPN scores, mitigation strategies, and template recommendations for…