how many types of cleaning validation
Can you elaborate your question as Cleaning Validation do not have types
Yes, calculating MACO have various different ways i.e by General limit, by TDD, by LD50 value and the lastly added MACO by PDE or ADE
If you can make your question more specific, I think I will be able to throw some more light
This is regarding cleaning validation MACO calculations.
based on TDD formula I calculated MACO. But as my products are having less dosage values and getting the limits like 0.2;0.1 ppm. For these limits I am unable to develop the method.
Can you all suggest the path to over come out from this issue. Because of this issue I am unable to completes cleaning validation.
Could you please give me an example of PDE calculation for a specific API? What if we cannot find out any data to calculate PDE/ADE?
At the moment, we use 0.001-dose and 10ppm specifications and I want to rebuild our validation strategy.
Hello Mr. Patel,
Could you please tell, how we can calculate PDE value and how and from we can find the F factor for different API? or to consult a toxicologist is mandatory.?or what you suggest how to deal with this !