Hi Charlie,
I had a one year contract in a nonacademic NMR lab that provided GMP sample
testing. My recommendation for the vast majority of academic labs is to avoid
heading in that direction. The sample turnover needed to justify the increased
staffing demands exceeds what most academic labs can sustain. Putting aside
the months/years needed to prepare your facility and train yourself/staff, I'd
anticipate friction with faculty over the daily particulars of GMP operation.
GMP is red tape and inflexibility to the extreme, which admittedly helps it
function as a consumer protection.
I've also experienced the lack of available training material. I'm told it's
an intentional gatekeeping measure and that learning GxP on your own is a
catch 22. Normally it takes many years to slowly accrue that expertise on
the job. For those of us without lengthy careers in GxP environments there
aren't many options to bridge that gap. Hilary's offer to describe the steps
her lab took is extremely generous.
Kind regards,
Luke
Luke Fulton, PhD
CHEM BLDG R003
NMR Core Facility Director
Unit 3060
COR2E & Department of Chemistry
55 N Eagleville Road
University of Connecticut
Storrs, CT 06279
email: fko24003_at_uconn.edu
(alias): luke.fulton_at_uconn.edu
mobile: (603) 953-5275
Office: (860) 486-4069
________________________________
> From: main_at_ammrl.groups.io on behalf of Sheahan, Charles Andrew via groups.io
> Sent: Friday, May 31, 2024 11:27 AM
> To: main_at_ammrl.groups.io <main_at_ammrl.groups.io>
> Subject: [AMMRL] Setting up an NMR facility to be GLP or GMP certified
Hi AMMRL land,
So, we've had a few requests of late so see our GLP and or GMP certification
after which I have to do some explaining that we're an academic entity and
we don't do that sort of thing.
I have also realized that I have no idea what getting this certification
would entail for an NMR facility and who, if anyone, regulates such things
(I assume someone does, but Google is of no help).
So... I have three questions for the group. 1) Have any of you accomplished
this? 2) Who decides what is necessary for certification and what isn't? Is
there a set of guidelines somewhere? and 3) If you did get your facility
certified, was it worth it?
Thanks,
-Charlie
Charles A. Sheahan
NMR Manager
Harvard Medical School
617-432-6025
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Received on Fri May 31 2024 - 11:18:59 MST