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Concluding Review Memo/E-mail for Rota CMC
|Sent:||Wednesday, April 02, 2008 12:12 PM|
|To:||Henchal, Laraine; Levis, Robin|
|Cc:||Feinstone, Stephen; Krause, Philip; Vujcic, Luba; Weir, Jerry P.|
|Subject:||concluding review memo/e-mail for Rota CMC|
Upon further discussion and review of the --------------- step and the in process controls to measure product quality after ---------------, it has been concluded that GSK's use of the - --------- is appropriate and there are no remaining issues regarding this step in manufacturing.