there is a great powerpoint presentation that you could download at
http://www.fda.gov/cber/summaries/pilaro2053100.ppt
abizar
www.innogenex.com
1-877IGX-INFO

"Morken, Tim" wrote:

> Thomas,
>
> This was posted awhile ago on the Histonet:
>
> Date: Fri, 24 Apr 1998 14:54:33 -0500
> From: ptakes@notesgw.sial.com
> Subject: Re: Good Laboratory Practice Complient
>
>
>
>  Rob:
>  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
> http://www.fda.gov 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
> http://www.access.gpo.gov/nara/cfr/cfr-retrieve.html#page1, 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
> Society, http://www.raps.org
>  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
> Practice").
>  Hope this is what you need.
>
>  Peter
>  Peter A. Takes, Ph.D., RAC Regulatory Affairs & QA Specialist SIGMA
> CHEMICAL COMPANY ptakes@notesgw.sial.com 1-800-521-8956, Ext. 3793
>
> Tim Morken, BA, EMT(MSA), HTL(ASCP)
> Infectious Disease Pathology Activity
> Centers for Disease Control and Prevention
> Ms-G32
> 1600 Clifton Road
> Atlanta, GA 30333
> USA
>
> PH: 404-639-3964
> FAX: 404-639-3043
>
> email: tim9@cdc.gov
>
> -----Original Message-----
> From: Thomas J. Kuwahara [mailto:tom@resolve3d.com]
> 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 - http:www.resolve3d.com
> 3801 Sacramento St., Suite 621, San Francisco, CA  94118
> T: 415/750-2307 F: 415/750-2332  E: tom@resolve3d.com