Re: IQ, OQ, PQ

Subject: Re: IQ, OQ, PQ
From: Kat Nagel <mlists -at- masterworkconsulting -dot- com>
To: "TECHWR-L" <techwr-l -at- lists -dot- raycomm -dot- com>
Date: Wed, 9 Jun 2004 14:18:35 -0400

At 10:28 AM -0400 2004/06/09, Liz Goodwin wrote:

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.

Have you checked the pharmaceutical industry section of the FDA web site?

They used to have nauseatingly exhaustive guidelines for absolutely every type of documentation that satisfied each relevant clause in the Code of Federal Regulations (CFR) that mandated the validation procedures. I used their guidelines when I was involved with a medical device manufacturer, and I'd be surprised if their pharmaceutical manufacturing stuff weren't at least as complete.

Kat Nagel, MasterWork Consulting

katnagel -at- masterworkconsulting -dot- com



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IQ, OQ, PQ: From: Liz Goodwin

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