Requirement of temperature data before dosing [Study Per­for­mance]

posted by ElMaestro  – Belgium?, 2017-07-20 10:13 (1122 d 02:38 ago) – Posting: # 17575
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Hi anky1212,

» Storage condition is to store product between 15-30 degree centrigrade

If you are not sure the IMP was stored within the storage recommendation interval, or that any deviations do not affect the quality (/safety/efficacy) then you should probably not dose any subjects with it. Storage conditions exist for a reason.

Quarantine the IMP, contact the sponsor to get a statement from the release office or QP. All this is likely a part of your QMS already.:-)

I could be wrong, but...

Best regards,
ElMaestro

"Pass or fail" (D. Potvin et al., 2008)

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