Residual analysis

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
#1

My question is concerning residual analyses performed on products containing multi APIs during cleaning validation.

I know that, according to the FDA regulations, we must perform a residual analysis for the API within a product during cleaning validation. If the product contains more than one API, are we supposed to perform individual analyses for each of the API within the product or can we choose a particular API, which has the lowest dissolution rate, and omit the rest of the analyses? I hope my question is clear enough.
Thanks for your concern, in advance.

#2

Dear friend,
with respect to your question I would suggest that the concept of the Cleaning Validation is based on the Worst Case Product. One of the parameters that lead to the choise of the worst case product is that of the solubility of the API. If the selected worst case contains more than one API in this case I would check both the APIs with respect to the selection factors of the Worst Case Product.

If one API is very soluble and the other one is practically insoluble I would proceed with my analysis based on the second one.

Hope it helps.

Best regards,

#3

Thank you Gigastorm for your clear explanation. You have been indeed very helpful.

#4

Dear friend,
to make it clear you must define the worst case matrix for which you are going to do cleaning validation. Some companies follow toxicity approach and solubility approach a combination of both. Thus if your product is coming into this category then you can do cleaning validation for that active. And one more thing you must be able to know the process whether it is able to produce any degradation products during its course of manufacture if so this need to be considered.