Charlie,
BTDT, but only in an industry setting.
There is no such thing as “a set of guidelines” (other than
the CFRs… and good luck parsing that) nor is there any way to buy
certification. You need an internal quality system for everything (hardware,
software, training, SOPs, data integrity, validation of methods, certification
of the operator and the instrument, etc., so it’s a monumental amount
of paperwork), and then you need to have your system audited by the FDA. If
you convince them that your systems are such that you have good control over
everything, then you’re in.
And, the next morning, you need to start ongoing validation/certification/verification,
with documentation.
I’d ask people why they want to see certification. If they need
quantification under GxP for something like a release test, then you are
100% on the hook. Essentially all other NMR work does not fall under GxP
per the CFRs and FDA guidance. Practically no big drug companies (OK, there
are a few, but they must be ruled by their QC people) run under certification
for anything other than quantification. GxP is essentially about proving
that some measurement you make is reliable and reproducible; it has nothing
to do with validating anything else.
Good luck!
-Dave Russell
> On May 31, 2024, at 8:27 AM, Sheahan, Charles Andrew via groups.io
>
> 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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