Requirement of temperature data before dosing [Study Per­for­mance]

posted by ElMaestro  – Denmark, 2017-07-20 12:13 (1551 d 09:08 ago) – Posting: # 17575
Views: 5,535

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.:-)

Pass or fail!
ElMaestro

Complete thread:

Activity
 Admin contact
21,737 posts in 4,546 threads, 1,543 registered users;
online 7 (0 registered, 7 guests [including 6 identified bots]).
Forum time: Monday 21:22 CEST (Europe/Vienna)

Law is mind without reason.    Aristotle

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