ABSTRACT
Cleaning validation is demonstrated assurance that a cleaning procedure reliably and reproducibly removes prior objectionable residue from a contaminated surface. Cleaning validation includes preparatory work to develop and support the cleaning method, demonstration of the cleaning procedure, including analytical determination of residues, and monitoring of continued acceptable cleaning performance. Several evolving approaches to general validation and qualification have profoundly influenced pharmaceutical development, manufacturing, post-manufacturing, and continued monitoring. Primary among these is the lifecycle approach to process validation. Cleaning and cleaning validation should be approached following the principles of the lifecycle approach to process validation. The Food and Drug Administration guidance clearly states that product manufacturers are expected to have sufficient knowledge and experimental data to have confidence that their processes consistently deliver a consistent and reliable product. Cleaning methods and associated technologies have evolved significantly. Cleaning validation is universally addressed in regulatory guidances and regulations, and fundamental concepts and principles have been widely discussed.
