Dear colleagues,
We are writing to apply for a NIH CMCR grant, and the PI wants to have
the small molecular compounds made and analyzed under GLP conditions to
facilitate future pre-IND filings with FDA. I have talked with a friend
and read about GLP in the internet. I understand there will be a lot of
record-keeping and calibrations required for NMR, HPLC and other
analytical instruments. I assume industry colleagues are all GLP or even
GMP environment. Rather than re-inventing the wheel, I am wondering
whether anyone knows any good resources or SOP samples that I can based
on to develop ours. I think as more and more academic people trying to
develop potential drugs or develop biotech companies, more labs will be
interested in setting up at least GLP environment to facilitate the late
stage pre-clinical studies.
Any suggestions are highly appreciated. You all have a nice weekend.
Best regards,
Wei Li
--------------------------------
Wei Li, Ph.D.
Associate Professor and Director of NMR Facility
University of Tennessee Health Science Center
847 Monroe Avenue, room 327A
Memphis, TN 38163
901-448-7532 (PH) 901-448-6828 (Fax)
http://www.utmem.edu/pharmacy/pharmsci/faculty/wli/
Received on Fri Oct 16 2009 - 12:01:33 MST