Re: IQ, OQ, PQ

Subject: Re: IQ, OQ, PQ
From: "Gene Kim-Eng" <techwr -at- genek -dot- com>
To: "TECHWR-L" <techwr-l -at- lists -dot- raycomm -dot- com>
Date: Wed, 9 Jun 2004 10:28:10 -0700

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
> (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
> 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
> I just need the organization thing.


SEE THE ALL NEW ROBOHELP X5 IN ACTION: RoboHelp X5 is a giant leap forward
in Help authoring technology, featuring Word 2003 support, Content
Management, Multi-Author support, PDF and XML support and much more!

>From a single set of Word documents, create online Help and printed
documentation with ComponentOne Doc-To-Help 7 Professional, a new yearly
subscription service offering free updates and upgrades, support, and more.

You are currently subscribed to techwr-l as:
archiver -at- techwr-l -dot- com
To unsubscribe send a blank email to leave-techwr-l-obscured -at- lists -dot- raycomm -dot- com
Send administrative questions to ejray -at- raycomm -dot- com -dot- Visit for more resources and info.

IQ, OQ, PQ: From: Liz Goodwin

Previous by Author: Re: Free, powerful graphics tool
Next by Author: Re: Free, powerful graphics tool
Previous by Thread: IQ, OQ, PQ
Next by Thread: Re: IQ, OQ, PQ

What this post helpful? Share it with friends and colleagues:

Sponsored Ads