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26th Jul 2012, 12:57 PM
#1
temporary aseptic facilities and IMP
Our aseptic air plant is on its last legs and will be replaced in the next 3-4 months. In the meantime we have to device a contingency plan of where to prepare the chemotherapy and one such plan is to use the aseptic facilities at a local hospital pharmacy department as a temporay measure.
Will I need to inform every Sponosr and the MHRA of a temporay change in facilities? The patients will still be treated at our hospital as normal. and the same trials staff will be carrying out the work.
Any help would be appreciated
Thanks!
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