Cleaning validation was once popular with inspectors as it was an “easy” way to find non-compliances. In 2021, data integrity seems to be the main area for observations. Click on the link above for more information on data integrity.

We have experience in the cleaning validation requirements for multi-product manufacturing suites as well as analysis methods for actives and detergent residues, clean and dirty hold time verification, and verification of campaign lengths for dedicated suites.

The hot topic a few years ago was the concept of the cleaning validation “train” where the potential contamination at each stage of manufacturing is taken into account to produce a global residual cleaning limit. More recently, auditors will look for compliance with the "new" guidance.