Re: GLP Regulations
William W. Ward, Ph.D., Wilford Hall Medical Center/PSLCI, (ward@WHMC-LAFB.AF.MIL)
Mon, 6 May 1996 08:20:54 -0500
>Date: Fri, 3 May 1996 16:43:54 -0800 >To: Cytometry Mailing List
<cytometry@flowcyt.cyto.purdue.edu> >From: cloxford@UCDAVIS.EDU (Carol
Oxford) >Subject: GLP Regulations > >I have a feeling I'm about to ask
a question that I don't want to be >answered, but... > >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? > > >Carol Oxford _| _|
_|_|_|_| _|_|_| >Medical Pathology Flow Cytometry Lab _| _|
_| _| >_| University of California _| _|
_| _| >_| Davis, California 95616 _| _|
_| _| >_| (916) 752-7205 _| _|
_| _| >_| (916) 752-4548 fax _|_|_|_|
_|_|_|_| _|_|_| >
Carol -
The standards are contained in 21 CFR 58. If you are certified under
CLIA '88 you meet the majority of the requirements. The main
additional requirements include detailed documentation sufficient to
reconstruct everything that occured to the specimens you test from
collection to final report, and the establishment of a quality
assurance unit/monitor. Although you test primarily animal samples,
before you get too concerned make sure your investigator is actually
involved in drug discovery/animal toxicology studies. The GLP's are
not directly applicable once a drug is in (human) clinical trials,
although the GLP __principles__ may be used in an FDA audit.
My experience has been with human Phase I-III clinical trials, so my
knowledge of GLPs applied to non-human preclinical trials is limited.
If you don't get more authoritative responses, please describe the
study in a little more detail and I will be happy to try to answer any
GLP questions you have.
Bill Ward
----------------------------------------------------- William W. Ward,
Ph.D. Immunology and Molecular Diagnostics Department of Pathology
Wilford Hall Medical Center
(210) 670-6838 FAX: (210) 670-7484 email: ward@whmc-lafb.af.mil
-----------------------------------------------------
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