Satisfaction? [GxP / QC / QA]

posted by Helmut Homepage – Vienna, Austria, 2019-04-12 18:59 (965 d 07:20 ago) – Posting: # 20155
Views: 2,486

Hi Mittyri,

» what were the temperature-time (exposure?) limits for that samples?

Upper limit –20 ℃. That is the validated long-term stability (>1 year) of the drug. We also know that samples are stable at room temperature for 16 hours.

» i.e. in what case would you request a satisfaction from WC?

Satisfaction in the meaning of a duel (fencing, pistols, choice of weapon by the challenger)? Duno, not my thing.
Responsible for the shipment was the clinical CRO. I’m sure it has a 10+ page contract in a 6pt-font with World Courier. If WC really would have screwed up, the second aliquot would not have been shipped.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,785 posts in 4,556 threads, 1,547 registered users;
online 12 (1 registered, 11 guests [including 8 identified bots]).
Forum time: Friday 01:19 CET (Europe/Vienna)

A drug is that substance which, when injected into a rat,
will produce a scientific report.    Anonymous

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