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.


Save up to 50% with RoboHelp Deluxe. Get 2 great products for 1 low price!
You'll get RoboHelp Office PLUS RoboDemo, the software demonstration tool
that everyone's been talking about. Check it out and save!

TECHWR-L is supported by ads and sponsorships...and donations.
You can help maintain the TECHWR-L community with donations

You are currently subscribed to techwr-l as:
archive -at- raycomm -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.

cGMP Validation: From: R D

Previous by Author: Re: Operational Manuals - Please Help
Next by Author: Re: Technically Speaking
Previous by Thread: cGMP Validation
Next by Thread: RE: cGMP Validation

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

Sponsored Ads