[Histonet] Pharmaceutical companies that perform IHC and GLPregulations???

[Liz Chlipala]

We have a bunch of general SOP's then we do have a separate SOP for each
antibody for all of our GLP IHC.  We also had to write a detailed SOP on
the dako autostainer and we then we performed a standard IOQ on the
instrument to validate it. It's a lot of work.

Liz 

Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC
Manager
Premier Laboratory, LLC
P.O. Box 18592
Boulder, CO 80308
phone (303) 682-3949
fax (303) 682-9060
liz <@t> premierlab.com
www.premierlab.com
 
Ship to Address:
 
Premier Laboratory, LLC
1567 Skyway Drive
Unit E
Longmont, CO 80504

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of
Christina Thurby
Sent: Tuesday, July 29, 2008 2:53 PM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] Pharmaceutical companies that perform IHC and
GLPregulations???


Hello,
Can any pharmaceutical people comment on how you are handleing SOP's
that are GLP compliant (21CFR Part 58)?  We currently are considering
whether we need to write an individual SOP for each antibody that we
perform by IHC.  We have general IHC SOP's in place now and have an
Antibody Specific Protol for each antibody in a Word document.  Any
comments are welcome.
Thanks,
Christina Thurby
812-429-8097


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