Bioequivalence and Bioavailability Forum

Hi s_b,

❝ (...) "after separation of the blood sample, polypropylene tubes containing plasma will be stored at -70 plus or minus 10 degree celsius "

❝

❝ If temperature has been observed up to 90 degree celsius during the shipment/ segregation, is it acceptable, kindly give your suggestion

1. It would be exceptional if the cooler temperature adversely affected the stability
-but-
2. Strictly the temprature is out of your specified range and a regulator may crack down on it.

Since you ask I assume that you did not receive two aliquots sent separately and where the other shipment was ok. I think you could try to quickly revalidate (accuracy and ... ?) after freeze/thaw to -90, but I acknowledge timing is a potential issue here. Apart from that you could consider a kind of capa here. Ask 5x why starting e.g. with: Why was the protocol specification 70 degs C +- 10 degs C? Why was the shipment out of this range?

Although the FDA may ask companies to increase their vendor oversight activities I have yet to see any company asking World Courier for permission to audit