DQ/IQ/OQ/PQ of NMR Spectrometers for GMP compliance

From: David Grace <DG_at_nycomed.com>
Date: Wed, 05 Jul 2000 11:01:31 +0200

Hello,

I am interested in getting in contact with anyone who has done full
DQ/IQ/OQ/PQ of their NMR spectrometer(s) for the purpose of GMP compliance.
Also those who have done this retrospectively. We are in this process now
and it would be of great help to me to share ideas on what should be
tested apart from the obvious instrument specifications.
for example:
>How do people treat validation of behaviour in 2D sequences.
>What about checking that when one measures T1 and sets delays accordingly,
> they really result in quantitative results ?
>How should NMR performance test samples be stored - do they have a maximum shelf-life?
>How best to store deuterated solvents etc. etc.

Lots of possible questions.

Also how many NMR labs out there are GMP-compliant?

Any input welcomed


David Grace
NMR group, Oslo
voice +47 23185006
fax +47 23186014
Received on Wed Jul 05 2000 - 10:26:19 MST

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