Consolidating reagents

[R1R2]

Does anyone know of any regulations prohibiting consolidating a reagent of the same lot and expiration date is not an issue?

Thanks for your replies,

R1R2

[David Saikin]

I don't think it is an issue . . . at least not for me.

[John C. Staley]

I'm with David, same lot, same exp. date, no problem. But......there may be an inspector/assessor out there that could disagree for some very strange reason. Be ready with a defense just in case. Remember it's not paranoia if they REALLY ARE OUT TO GET YOU!

[David Saikin]

Like John says - even more than them being out to get you is the fact that many inspectors (CAP particularly) are not the most experienced folks in the area they are inspecting. Don't be afraid to stand up for what you are doing . . . you can always fight a citation if you feel good about your process. Just 'cuz you are cited does not mean you are non-compliant; let the regulating body make that decision.

[R1R2]

Thanks guys. I will tell the techs not to do it in front of an inspector.

[Mabel Adams]

I think you should do any consolidating right before you run QC on the off chance that one batch has been contaminated or neutralized. The worst you would be doing is ruining a larger supply of reagent so that it didn't pass QC but that would be very rare. You might be able to use these arguments with inspectors. The only caveat might be JC because they specifically require QC on any open vial of reagent, not just the same lot.