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Post authorisation USA (FDA post approval reporting categories (Moderate…
Post authorisation USA
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SUPAC-scale up post approval changes-size of batches small pre approval,SUPAC scale up after approval just for manufacturing
SUPAC IR,SUPAC MR,SUPAC SS
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Biologics-biological product deviation reports-report from MAH of any deviations to cGMP,regulatory standards,specifications that may affect.Reporting time after 45 days,ideally ASAP
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