Cleaning Validation of COP/CIP Systems in Pharma: A Step-by-Step Compliance Guide Step-by-Step Guide to Validating COP and CIP Cleaning Systems in Pharma Introduction Clean-in-Place (CIP) and Clean-out-of-Place (COP) systems are automated or semi-automated cleaning technologies widely used in pharmaceutical manufacturing. Their validation is critical to ensure effective residue removal, equipment cleanliness, and regulatory compliance as per FDA 21 CFR 211.67, EMA Annex 15, and WHO GMP. This article presents a detailed, step-by-step strategy for validating COP/CIP systems, covering acceptance criteria, swab/rinse sampling, MACO calculations, and documentation best practices. Understanding COP and CIP Systems CIP (Clean-in-Place): Automated cleaning performed in a…