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
-----------------------------------------------------
CD-ROM Vol 3 was produced by Monica M. Shively and other 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: (765)-494-0757;
FAX(765) 494-0517;
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