Marker setting

[pat]

dear all

I have a question here, we need to do assessment of ingredients used in the process for the cleaning validation (ex: solubility, toxity, potency), but the description about this is just focus on drug substance, than how about the cleaning validation for drug product?

since we all know that ecipient don’t have the concern about their toity, do we still need to assess ecipients, like other factor may effect the quality of next product?

and we all know that swab recovery is the most important factor for swabing, than should we put this research in analytical method validation protocol or it should be done before we do valdiation?

thanks for the kind reply~

[Ravi_Dhanbhar1]

Answer of first question lies in queston itself. I mean only active drug substance is considered for MACO & suitable marker for solubility, toxity, potency need to be used for assessment of challenge.
You can have sensitivity & recovery study using suitable coupons to represent contact surface.
Finally it is expected to use worst case substance for this study.
Rgds
Ravi Dhanbhar