Re: cGMP Validation

Subject: Re: cGMP Validation
From: Dick Margulis <margulis -at- fiam -dot- net>
To: "TECHWR-L" <techwr-l -at- lists -dot- raycomm -dot- com>
Date: Tue, 13 Aug 2002 06:56:36 -0400

R D wrote:

Dear List,

Could someone explain to me what "cGMP Validation" is
or point me towards some online resources?


cGMP is an FDA standard, "current Good Manufacturing Practices," that applies to the manufacture (but not the design and development) of regulated medical devices (and maybe also to pharmaceuticals--I'm not certain about that). The equivalent on the design side is the Quality System Regulation (QSR). You should read the regulations themselves, on the FDA site, before you get lost in third-party interpretive materials.


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cGMP Validation: From: R D

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