RE: RE: New building - Variation? Contribution from Alex Karory written on 1/26/2012 at 21:53
Original contribution: RE: New building - Variation? written by SAURABH... on 1/26/2012 at 17:32) Basically variations are for the modifications that are brought to the product. If there is no batch size change, no formulation change, no process change I will say no variation should be needed. But identity of manufacture should be 100% documented and kept within the company. For US dossiers please refer to SUPAC rules, it ison of the cases that are described. Answers to this contribution:
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