Re: lab certification

SDSNMR@aol.com
Sat, 11 Nov 1995 00:20:18 -0500

>Hi,
>
>Recently our lab is becomming GMP/GLP compliant. I was
>wondering if I could get some help from anyone who has
>undergone this process.
>
>Specifically:
>
>1. What calibration/standardization test do you perform
> on your NMR instrumentation?
>
>2. Do you do this monthly, quarterly etc.?
>
>3. Were these test you developed our used a some
> "official" publication of tests that are to be used?
>
>
>I would also be interested if your lab does this for
>its other instrumentation(ie. MS, IR, etc.).
>
>
>Thanks very much,
<I would also be interested if your lab does this for
<its other instrumentation(ie. MS, IR, etc.).
<
<
<Thanks very much,
<
<
<Brian Tobias
<Parke-Davis
<2800 Plymouth Road
<Ann Arbor, Michigan 48105

Hello all

Whenever we switch nuclides, which is fairly often,
we first run a standard, and check the linewidth,
S/N, pi/2 value, and the offset; this is, of course,
SOP driven. We also run these tests daily, if there
has been no nuclide change. This is done for all
nuclei, and for both solids and liquids. The results
from the setup tests are recorded in the instrument
logbook.

We are also starting a yearly validation test, in which
integration of 1:1, 1:10, and 10:1 mixtures of two
standards are run for H-1, C-13, and P-31, in
triplicate, by two different operators; obviously,
we then check to insure that the integral areas
match with the composition. We also test
2D COSY and HETCOR at this time.

To the best of my knowledge, there are no official
tests for the testing and validation of NMR
spectrometers. Given this, all you can do is
devise tests of your own, which demonstrate that
the NMR spectrometer is operating within your
user-defined specifications.

Gary
************************************************************************
Gary Turner
Spectral Data Services, Inc. Contract NMR Data Acquisition
phone : (217)352-7084
fax : (217)352-9748
email :sdsnmr@aol.com
http://www.prairienet.org/~glturner/sdsnmr.html