Re: GLP Regulations
PAUL@flowcyt.cyto.purdue.edu
Mon, 6 May 1996 09:33:22
Carol Oxford asks about GLP... What is required is that you have all
proceedures written out in detail, stating exactly what the steps of
each assay are, including making up buffers, reagents, QC of instrument
etc. You must then certify that this is correct, nominate a "trainer"
who certifies everyone else, then stick to the methods like glue.
There is a lot of paperwork for GLP (otherwise know as Great Lots of
Paper). There is no specific GLP method for flow cytometry, you
basically make up your own. Remember GLP really says nothing about the
"correctness" of a proceedure, only that you blindly follow what ever
is written down in your GLP "manual". Paul
> I have a feeling I'm about to ask a question that I don't want to be
> answered, but... > > Our "flow lab" is a research facility which
houses a FACScan. The > samples we run are mostly primate, canine and
feline. I have just been > informed by one of our investigators that
they are conducting a study > to obtain FDA approval of a new drug, and
that I need to operate by GLP > standards. Can anyone direct me to the
easiest way to determine what > these standards are for a flow lab and
what changes I need to > implement? I was informed of this situation
on Friday at 3:00, and my > first samples are arriving on Monday. (If
you know what I will need to > do, and you think I should quit my job
and apply at McDonald's, I will > definitely give the advice some
serious consideration!) > > Thanks in advance, > > Carol Oxford
J.Paul Robinson, Purdue University Cytometry Labs
robinson@flowcyt.cyto.purdue.edu PH:317-494 6449 FAX:317-494 0517 web
http://www.cyto.purdue.edu
CD ROM Vol 2 was produced by staff at the Purdue University Cytometry Laboratories
and distributed free of charge as an educational service to the cytometry community.
If you have any comments please direct them to Dr. J. Paul Robinson, Professor & Director, PUCL,
Purdue University, West Lafayette, IN 47907. Phone:(317) 494-0757; FAX (317) 494-0517; Web http://www.cyto.purdue.edu
EMAIL robinson@flowcyt.cyto.purdue.edu
