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There really isn't any such thing as a standard IQ/OQ/PQ format, just
a set of requirements that need to be satisfied. You'll need to tailor
your protocols to the specific requirements that cover your product.
All of the protocols I've created are too proprietary to share, but there
are a few instrument manufacturers that have posted some of their
obsolete ones to the web. There's a halfway decent one at
Just keep in mind that it is an old document, and may not meet the
most current requirements. Frankly, if your company has
never done these before, I would highly recommend the use of a
good validation service for the first go-around. You can then use
your first set of successful protocols as a template for future ones.
Gene Kim-Eng
----- Original Message -----
From: "Liz Goodwin" <Liz -dot- Goodwin -at- ametek -dot- com>
To: "TECHWR-L" <techwr-l -at- lists -dot- raycomm -dot- com>
Sent: Wednesday, June 09, 2004 7:28 AM
Subject: IQ, OQ, PQ
> Hi Everyone!
> I'm in desperate need of any kind of template (or pointing in the right
> direction) that can be used in a Validation Support Package for the
> installation of instrumentation into a pharmaceutical manufacturing site.
> This would include Installation Qualification (IQ), Operation
Qualification
> (OQ) and Performance Qualification (PQ). I've checked the internet and
> mostly what I get is an explanation of what it is - but not "how" to do
it.
> Several companies contract to do it, but we are going to do it in-house.
> This would be for a process analyzer, but probably any instrumentation
> would be a good starting place. I have a basic idea of what has to be
done,
> I just need the organization thing.
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