GLP for non-clinical labs (research)

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From:Cathy Mayton <Cathy@wasatchhisto.com>
To:histonet@PATHOLOGY.swmed.edu
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One of the best places to get information about GLP is from the GLP Guru,
Paul Lepore.  His web site is www.glpguru.com

I have set my lab up GLP compliant and have contacted Paul personally by
phone and email.  His is very helpful and so is his web site.  It took over
a year to get the lab GLP compliant and ready for our first Quality
Assurance (QA) audit by one of my clients (January 1999).  We have since
had 3 QA audits from different clients and completed our first GLP study in
March.  

It is a lot of work but I believe it is worth it.  I can work with  my
clients through all the R&D work and when they are ready to file a study
with the FDA, they aren't looking for another lab.  We now have 3 GLP
studies lined up for the fall so it has been well worth the effort for me.

One thing to keep in mind is that you need an internal QA unit.  This can
be a part-time person but they MUST be independent of the work performed
for GLP studies.  If you have any more questions, please feel free to give
me a call.

I got lots of help from other labs who were already GLP compliant and I
attended a QA workshop in April.  So between the labs, the workshop and
Paul Lepore we are doing very well.  It sounds like we need a NSH workshop
to help labs get on the road to GLP compliance.

Best regards,
Cathy

   

***************************************
GLP Compliant Laboratory 

Cathy A. Mayton
Wasatch Histo Consultants, Inc.
80 Youngberg Road
Winnemucca, NV   89445-5709
Voice:  (775) 625-4425
Fax: (775) 625-1548
www.wasatchhisto.com
***************************************




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