Satisfaction? [GxP / QC / QA]

posted by Helmut Homepage – Vienna, Austria, 2019-04-12 18:59 (560 d 21:11 ago) – Posting: # 20155
Views: 1,858

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.

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Helmut Schütz

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