Requirement of temperature data before dosing [Study Per­for­mance]

posted by ElMaestro  – Denmark, 2017-07-20 14:13 (2443 d 23:06 ago) – Posting: # 17575
Views: 6,169

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:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
108 visitors (0 registered, 108 guests [including 10 identified bots]).
Forum time: 12:20 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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