Analytical method for cleaning validation

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Hi!

I am defining the products than they should to included in the cleaning validation process; but I have a doubt about the analysis of the worst case:

One of these products has two actives, but only one correspond to the worst case; the two actives are analysed for two differents assay methods; one method work is with HPLC (worst case) and the other one is by titration.

I have tried to change and of find an assay method for the second activo (titration), more specific (HPLC), but there isn’t, just I have find, methods that work there are methods that wear specific detectors (fluorometric, etc); the wich ones we don’t have.

To cleaning validation process. Should I consider the two actives to cleaning validation? or Should I consider just the active definite as worst case (HPLC method?

Best regards,

2

Dear Carlos…
You can consider the worst case product as target and you can proceed your validation studies. But, you need to prove the specificity of your analytical procedure to your target in presence of your second API.

Regards
RAJU

3

Hi,

Thanks for your answer.

Then, Is not neccesary to include the second API during the cleaning validation process (testing with manufacturing equipment).

Regards,

4

Not required. however, it can present in test sample. but, no need to quantify.