Application note: Calculating maximum allowable carryover (MAC) for cleaning validation

This application brief presents a framework for how to establish acceptance criteria limits using TOC to comply with FDA best practice guidance for the life cycle approach to cleaning validation.

The United States Food and Drug Administration (FDA) released guidance for current Good Manufacturing Process (cGMP) validation in January 2011. ¹ Within that guidance, the traditional approach of process validation has been replaced with a life cycle approach as the best practice recommendation. The life cycle approach is broken into three stages: Design, Qualification, and Verification. The three stages are no longer viewed as static steps but rather dynamic stages to be constantly reviewed and updated during the lifetime of the process. This new direction for process validation applies directly to cleaning validation (CV) as well.