Cleaning Validation-ADE Concept


(Md.Asif Hussain) #1

Dear All,

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::

  1. 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.?

(Arvind) #2

What is ADE


(Md.Asif Hussain) #3

Acceptable daily exposure.


(Arvind) #4

How to calculate ADE CAN U PLEASE SHARE WITH ME PLEASE


(Md.Asif Hussain) #5

Dear All,

Could you please provide me how can I get the ADE values of my products/API ?
Could you please mention agency names or toxicologist, where I can get it?

Thanks