Shipment of Investigational Medicinal products [Regulatives / Guidelines]

posted by qualityassurance – 2024-11-06 15:15 (599 d 09:36 ago) – Posting: # 24263
Views: 3,510

Dear Ohlbe,

❝ Not yet winter, please... Give us some more mild and sunny Autumn days !

Ohh! My bad!! Enjoy the last few sunny Autumn days :ok:

❝ I would not find it shocking, if there are no specified storage conditions. In any case if the temperature is monitored by data loggers you will be able to quarantine the products when received, and if needed, to replace them in case of temperature excursion (what I would be worried about when winter really comes is freezing temperatures).

:ok:

❝ Strictly no risk for the trial participants.❝

Indeed. as long as temperature does not cross 40 degree during transportation

❝ Only risk for the sponsor: having to buy some reference product again, and loosing some time. Their problem.

Yes. Taking risk when RLD is not costly and have enough timeline.

Extremely sorry for very bad formatting. [No problem; corrected. Helmut]

Regards,
QA

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
197 visitors (0 registered, 197 guests [including 13 identified bots]).
Forum time: 01:51 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks.    Jimmy Wales

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