Bio Batch Size [Design Issues]

posted by wienui – Germany, Oman, 2019-05-11 15:27  – Posting: # 20279
Views: 936

(edited by wienui on 2019-05-11 20:29)

Dear Imad(ov),

» The question is :
» If we prepare a Qty of granules of bio-batch equivalent to 100 000 finished product units and compress only about 30 % of the final blend of granules Qty ( means to get about 30 000 to 35 000 tablets without completing the compression stage with continuing the film coating and the other QC testing for the produced tablets )
» Can we consider this compressed Qty as a representative batch and justified to be used in the Bio-Equivalency study ?

The EMA GL says the test biobatch should be representative of the product to be marketed which is in this case 30 000 to 35 000 tablets (lower than 100.000 units) and don't say representative of the product to be produced, therefore the answer of your question is: you can't.
As long as the biobatch is less than 100.000 then scaling up is not allowed.

Best regards,


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