Elevating Cleaning Validation to Tackle FDA Observations

Azzur Group's Comprehensive Approach

A recent increase in FDA warning letters underlines the need to refine cleaning validation programs by incorporating worst case scenarios into the assessment process. These scenarios involve various aspects of drug properties, cleaning methodologies, and microbial risks. Register to download this whitepaper to…

1. Demystify the FDA's rigorous expectations outlined in the recent FDA 483 and Warning Letter observations.
2. Review a comprehensive plan to systematically address the new challenges being presented.
3. Define and identify worst case products for cleaning validation.