As per the PDA TR 29 guideline for Cleaning validation,ADE concept is introduced for worst case evaluation and Calculating of acceptance criteria,So Could you please tell me how i can these following::
- ADE values for my API (Around 210 Nos)
2.Which organisation is providing these data?
3.How much it will cost?
4.Is the value or acceptance criteria calculation is tighter than existing 10ppm and Max. accumulation 1/1000 of Max Acceptable daily intake criteria.?