Cleaning validation

Do we need an analytical method for cleaning validation of Non-drug products, For Example: for cleaning validation of drug product is required an analytical method to detect samples?

Cleaning validation is required for Active compounds,
However, if you are using only excipient in certain equipment, then Physical cleanliness and microbial test is required.


1 Like

Cleaning validation for API manufacturing n Finished Pharmaceutical manufacturing is same?

The major objective is to obtain documented evidence that your cleaning procedure is adequate to prevent cross contamination from one product to another. That’s in both API and finished product manufacturing. The overall approach would generally be the same.
Difference is that in finished product manufacturing you also need to factor in the different excipients used in different dosage forms. GMP Annex 15 states: β€œ10.6. Limits for the carryover of product residues should be based on a toxicological
evaluation.” Product residues includes excipients. So risk assessments in finished product manufacturing would be a lot more complex than in API manufacturing.