Analytical testing is expected at each changeover unless justified via a robust, documented Quality Risk Management (QRM) process.

The QRM process should consider, at a minimum, each of the following:

– the repeatability of the cleaning process (manual cleaning is generally less repeatable than automated cleaning);

– the hazard posed by the product;

– whether visual inspection can be relied upon to determine the cleanliness of the equipment at the residue limit justified by the HBEL.