Cleaning validation/varification method

Dear all
We are manufacturing the X product. The intermediate of X product is also being manufactured by us. The cleaning validation has to de done for intermediate. The testing for detection of intermediate was performed by UV, HPLC and TLC .There is no response (Detection) in UV, HPLC and TLC .What we should do. How we ensure that the manufactured intermediate has been removed completely. The intermediate product is insoluble in water; it’s soluble in solvents only.
Please share your ideas and views.

R C Pantola

Dear R.C.Pantola,

I think there is some need for clarification. As you deal with intermediates I assume the issue is in the API production. But in that case there should or may be an analytical method to quantify the intermediate in the finished product, because it is a probable impurity, and as such you may have a specification for the maximum contamination of the intermediate, regardless whether it comes from the starting material or from contaminated equipment. As you see, at least for me the issue is not too straightforward, and some more details would be helpful.

Best regards