Here I go again[Histonet] Expiration date (Joe Nocito)
mucram11 <@t> comcast.net
mucram11 <@t> comcast.net
Tue Jun 21 08:32:59 CDT 2005
Jackie,
You weren't suppose to tell everyone.
Generally when it is re-tested by the manufacturer it is given a new lot number and the records are combined or noted according GMP or other regulating body so it is legal. This way we can't tell what they did based on our current lot numbers that are expiring and may even buy the same lot with a new number and expiration withnot realizing it.
They are generally careful to re-test and comfirm the validity of the product be it antibody or other reagents before doing this.
Pam Marcum
-------------- Original message --------------
> I believe even manufacturers of antibodies will change the expiration date
> of a product after it has been re-tested and found to be still potent.
> They don't want to throw away a ton of good material, either. But,
> they'll change the lot number.
>
>
>
>
>
>
> "Joe Nocito"
> Sent by: histonet-bounces <@t> lists.utsouthwestern.edu
> 06/20/2005 03:21 PM
>
>
> To: "Todd Sherman" ,
>
> cc:
> Subject: RE: Here I go again[Histonet] Expiration date (Joe
> Nocito)
>
>
> Todd,
> I do not expect a manufacturer to guarantee any reagent beyond its
> expiration date, but if the QC is done properly, with the proper
> documentation to back it up, throwing away good reagents just doesn't make
> any sense to me.
>
> Joe
>
> -----Original Message-----
> From: histonet-bounces <@t> lists.utsouthwestern.edu
> [mailto:histonet-bounces <@t> lists.utsouthwestern.edu]On Behalf Of Todd
> Sherman
> Sent: Sunday, June 19, 2005 3:41 PM
> To: histonet <@t> lists.utsouthwestern.edu
> Subject: Re: Here I go again[Histonet] Expiration date (Joe Nocito)
>
>
> Joe,
>
> Regarding "If an antibody expires June 30, 2005, does it automatically go
> dead on July 1?" - according to the corporate legal teams and their
> liability concerns, of course. ;)
>
> But in all seriousness, you bring up a good point. I can understand a
> manufacturer needing to maintain QC and establish liability limits, not to
> mention bump potential premature boosts in sales from the dumping of
> viable product by enduser, but some modification should be considered. You
> mention a nice protocol of aliquoting, inventorying, and testing that
> seems entirely reasonable. Consider another lab that dumps lots according
> to date but that doesn't aliquot properly and lets an undiluted lot freeze
> and thaw such that it "expires" before the label date would indicate it
> has deteriorated. Would such a scenario be better? Obviously a more scaled
> weighting that considers the continual QC testing against positive and
> negative controls should be incorporated since that is the fundamental
> concern.
>
> If a lab can produce a series of time-dated QC test samples/slides
> associated with a particular lot/vial/aliquot that proves efficacy, then I
> should think that the Ab is still "good". Granted, the manufacturers
> should not be held responsible for extended usage beyond what they deem
> reasonable/optimal; however, thoughtless disposal of good product should
> not be a mandate by the governing histological agency either.
>
> $0.02 worth of validation.
>
> Regards,
> Todd
>
>
> Todd Sherman
> President
> HistoSoft Corporation
>
> www.histosoft.com
> Biology In A New Form (c)
>
>
> On Sun, 19 Jun 2005 12:00:23 -0500,
> wrote:
> >
> > Today's Topics:
> >
> > 1. Here I go again[Histonet] Expiration date (Joe Nocito)
> >
> > ----------------------------------------------------------------------
> >
> > Message: 1
> > Date: Sat, 18 Jun 2005 12:20:47 -0500
> > From: "Joe Nocito"
> > Subject: Here I go again[Histonet] Expiration date
> > To: "Katia Cristina Catunda" , "histonet"
> >
> > Message-ID: <009701c5742a$118674c0$b4bd0b43 <@t> yourxhtr8hvc4p>
> > Content-Type: text/plain; format=flowed; charset="iso-8859-1";
> > reply-type=response
> >
> > Okay,
> > I've been too quiet for too long. Here I go again.
> >
> > I am so tired of CAP and their ridiculous regulations. Every CAP
> > inspection
> > I fight this same question. When I was supervising the Immuno lab at
> > AFIP,
> > we froze concentrated antibodies at -70 for years. Antibodies that were
> > frozen in 1080, were still viable in 1990. That means we were running
> > immunos in 1990 with 1980 prices. What is so wrong about that?
> > We also ran a known positive control with each batch. If the
> positive
> > control worked, guess what? The antibody was still good. If the positive
> > control did not work, we threw out that lot number and repeated it with
> > another lot number. When we saw that there was a drop in the staining
> > intensity, we tossed that lot and started another. My experience with
> > antibodies is that they just don't go bad over night, they start
> staining
> > with less intensity.
> > I think that the CAP board members have stocks in the biochemical
> > companies. Please don't get me wrong, I have many close friends that
> > work in
> > the biochemical side of this, but why would this drastic change in view?
> > The
> > FDA? I doubt it.
> > Maybe I'm too one sides on this issue, but give me a break! If the
> > positive control works in any other antibody, doesn't that mean the
> > antibody
> > is viable?
> > I know companies have to put an expiration date on their products,
> > but
> > come on. If an antibody expires June 30, 2005, does it automatically go
> > dead
> > on July 1?
> > As managers and supervisors, we are continuously bashed about saving
> > money. This would be a great place to start, don't you think?
> > That is all. Thank you
> >
> > Joe Nocito BS, HT(ASCP)QIHC
> > Histology Manager
> > Pathology Reference Lab
> > San Antonio, TX
>
>
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