Re: [AMMRL] Setting up an NMR facility to be GLP or GMP certified from Jenkins, Hilary on 2024-05-31 (Email Archives for May, 2024)

From: Jenkins, Hilary <jenkinh_at_mcmaster.ca>
Date: Fri, 31 May 2024 16:07:50 +0000

Hi Charlie

We did it, we don't do it anymore. It's a colossal amount of work which I can describe if you're interested (or if anyone else is). We were licensed by Health Canada as a testing facility, we underwent regular audits etc. etc.

It's not that the science is difficult because it isn't, but the approach is counter-intuitive to research. We maintained the research facility and did not dedicate one instrument to GMP testing. Industry usually has the capacity to restrict one instrument (and at least one person) to GMP testing, we did not have the bandwidth to do this, but we were successful in obtaining the license because we locked down the instrument(s) while running the samples.

This says nothing about the amount of background paperwork you need to do in order to build your quality system. It took us almost two years to have all the SOPs in place for that, and that was starting from SOPs that were good enough for research.

Once you have the quality system in place, you can ask the FDA (or other governing body, depends on who certifies you as GMP-compliant) to come and audit your system. I would suggest you have a consultant do this first so they can give you a gap analysis prior to the "real" audit...if you decide to do this.

I'm glad we did it, I'm more glad that we don't do it any more.

Let me know if you want more information.

-Hilary

Hilary A. Jenkins, PhD

Research Scientist, NMR Facility

Core Facility, Faculty of Science

McMaster University, ABB-A104
1280 Main Street West
Hamilton, ON L8S 4M1

location: ABB-112D (office)
cell: 289-339-4277
email: jenkinh_at_mcmaster.ca

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From: main_at_ammrl.groups.io <main_at_ammrl.groups.io> on behalf of Sheahan, Charles Andrew via groups.io <Charles_Sheahan=hms.harvard.edu_at_groups.io>
Sent: May 31, 2024 11:27
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 - 09:11:02 MST

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