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Is analytical testing required at product changeover, on equipment in shared facilities, following completion of cleaning validation?

01/07/2021 | 3199

Similar question:

Reply:

Analytical testing is expected at each changeover unless justified otherwise 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.

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