Requirement of temperature data before dosing [Study Per­for­mance]

posted by ElMaestro  – Belgium?, 2017-07-20 12:13  – Posting: # 17575
Views: 4,490

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

Complete thread:

Activity
 Admin contact
20,126 posts in 4,245 threads, 1,383 registered users;
online 10 (0 registered, 10 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 21:14 CET

Genius is that which forces
the inertia of humanity to learn.    Henri Bergson

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5