Re: GLP protocols

From: Mark Kukuruga (kukuru@med.umich.edu)
Date: Wed Feb 06 2002 - 11:43:59 EST


Chris, all . . .
That link has changed to . . .
http://www.fda.gov/cber/minutes/workshop-min.htm
. . . go down the page to the meeting title as Chris has indicated.
MAK.

>>> Christopher Groves <groves@mpi.com> 02/05/02 17:00 PM >>>

Eva,
The starting reference we have used is "Safety Issues Pertaining To the
Clinical Application of Flow Cytometry to Human-Derived Cells Public
Meeting and Workshop" from an FDA discussion last April
("http://www.fda.gov/cber/minutes/flocyt042001p1.htm"). I'm not sure if
I'm addressing your question, but if your application is cell sorting
under GLP/GMP conditions, this is a good start. Cytopeia, Inc. is
rumored to be working on a GLP/GMP cell sorting solution, according to
Cytomation's web site. I made an inquiry to the list some months ago and
was surprised by the lack of response, especially from the major
manufacturers, concerning this growing issue. Perhaps those who attended
the event could provide some further insight. Best of luck.
Chris

Chris Groves
Millennium Pharmaceuticals Inc.
75 Sidney Street
Cambridge, MA 02139
617-679-7495
groves@mpi.com



Eva Rakasz wrote:

> Dear Flowers,
>
> Could anybody help me out with some references to establish good
> laboratory practice (GLP) in flow cytometry facilities?
>
> Thank you for your help



This archive was generated by hypermail 2b29 : Sun Jan 05 2003 - 19:25:58 EST