Applying a Quality Risk Management Approach to a Cleaning Validation System

Abstract

Cleaning Validation is a crucial step on assuring product effectiveness and safety by assuring that the equipment to be used has the appropriate condition to manufacture a new product without any foreign substances that could endanger the patient to ingest this product. A quality risk management approach was used to see possible risks on a cleaning validation system and give recommendations in order to mitigate and control those the risks by seeking options to access does risks in an effective and reliable manner. FDA 21 CFR 210-211 was used as a guide for regulations regards cleaning validation systems. Key Terms - Cleaning Validation, FMEA, PAT, Quality Risk Management.