Rinse Recovery for API

Dear All,

Pls. let me know that, If once we performed Rinse Recovery for any perticular product as per 10ppm MACO & due to change in manufacturing block / MACO / matrix, if we have to Revalidate the cleaning procedure so is there Rinse recovery performed again or we can considar privious correction factor.

Thanks & Regards,

Ashvin Acharya

In my opinion if your rinse solution or equipment surface type is changed then only recovery study should be again performed.