Bioequivalence and Bioavailability Forum

Hi Loky do,

❝ I have a strange case which up to my humble knowledge occurs exclusively here in Egypt , at the start of autumn, the government changes the local time to winter time (minus one hour), …

Not only in Egypt but in many regions outside the tropics (mainly in the Northern Hemisphere).

© 2013 TimeZonesBoy @ Wikimedia Commons
 regions performing time switches    regions formerly performed time switches    regions never performed time switches

Even more confusing, the switches are not performed at the same date and/or local time. See there and also this post with a personal story at the end. You are not alone.

❝ … and we already locked the changing of time in LCMSMS instruments and on that night, we took all the precautions to ensure that the windows are not synchronized with the time to prevent this case from occurring. All instruments' time didn't change except one instrument had an unexpected change , it had a sequence overnight and inside the batch of 3 volunteers the time has repeated, so we have the same time for two volunteers , accordingly the optimum option is to:

❝ 1-only report the case after performing a quality investigation and not perform reanalysis of the batch,

❝ 2-or to perform a reanalysis of this batch

I would opt for #1.

❝ what is the optimum option to be accepted by authorities

I guess they would be fine with documented ‘Corrective and Preventive Action’ (CAPA) in order to rule out that it will happen again.