RE: Good Laboratory Practices

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From:"Morken, Tim" <>
To:HistoNet Server <>
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This was posted awhile ago on the Histonet:

Date: Fri, 24 Apr 1998 14:54:33 -0500 
Subject: Re: Good Laboratory Practice Complient 


 There are a number of guidelines and books available for GLP.  I suggest
going for the free stuff first.  Start with the FDA's web site at and go to the Center for Veterinary Medicine [CVM], and
look though their guidance documents.  Something should be there.  Also go
to the Human Drugs [CDER], Biologics [CBER], and Devices [CDRH] sections,
they too probably have guidance documents on GLP.  Most of the centers
within FDA overlap on the applicability of things like GLP guidance.
 Also, if you want federal regulations, GLP is covered under Title 21 of the
Code of Federal Regulations Part 58.  Can get a copy of sections from Part
58 downloading from, but it probably
would take a while to search for and download everything.  Plus, you need to
know section numbers.  For I think about $25, you can order a copy of Part
58 as a "pocket guide", a small book about 3.5" x 6.0" (I use the
regulations pocket guides a lot), from the Regulatory Affairs Professionals
 You may want to ask for a catalog from Interpharm Press (1-847-459-8480).
They have a lot of books providing regulatory information and assistance,
including GLP (e.g., "GLP Essentials: A Concise Guide to Good Laboratory
 Hope this is what you need.

 Peter A. Takes, Ph.D., RAC Regulatory Affairs & QA Specialist SIGMA
CHEMICAL COMPANY 1-800-521-8956, Ext. 3793

Tim Morken, BA, EMT(MSA), HTL(ASCP)
Infectious Disease Pathology Activity
Centers for Disease Control and Prevention
1600 Clifton Road
Atlanta, GA 30333

PH: 404-639-3964
FAX: 404-639-3043


-----Original Message-----
From: Thomas J. Kuwahara []
Sent: Monday, July 31, 2000 6:26 PM
To: HistoNet Server
Subject: Good Laboratory Practices

Dear Histonetters:  Can anyone out there point me towards a good source
for information about GLP for research labs? Regulations, rules,
documentation, etc.
Thanks, Tom
Thomas J. Kuwahara - Senior Immunohistochemist
Resolution Sciences Corporation -
3801 Sacramento St., Suite 621, San Francisco, CA  94118
T: 415/750-2307 F: 415/750-2332  E:

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