Posting: # 16754
Provided that a lab scale batch of a generic formulation demonstrated bioequivalence to the RLD how big would be the risk of commercial scale batch to fail?
IMHO factors affecting the formulation after method transfer to the CMO are different manufacturing equipment and different total amounts of drug and excipients. If the formulation and the manufacturing process remains the same and all characteristics and specification of critical quality attributes of the drug product, such as dissolution are met wouldn't it be reasonable to assume bioequivalence for the commercial scale batch? Do you have any experience with failed upscaling?
CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** states for oral solid forms for systemic action that "the test product should usually originate from a batch of at least 1/10 of production scale or 100,000 units, whichever is greater, unless otherwise justified." Considering this upscaling shouldn´t really be a problem, right?
Looking forward to your reply
Kind regards and have a nice day