Three Ways of Finding and Reading Information
 CFR Index Search
The search presents all relevant interpretations for each paragraph or subparagraph in 21 CFR210 and 211. Get an interpretation summary or open the original text in PDF format. You can also check to see if there are any relevant Warning Letters related to a specific paragraph.

Keyword Search
We have defined more than 600 important and commonly used keywords to help you in your search for the paragraph or interpretation document that you need.

Free Search
This enables you to search with your own word or phrase to pull up paragraphs and interpretation documents that fit your criteria.

First Edition
The first edition covers US GMP 21CFR 210 and 211. Other GMPs, for example, EU and Medical Device will be included in the future.

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We offer a 14-day project subscription. If you decide to upgrade to an annual subscription within 30 days of your initial subscription, we will apply your 14-day project subscription fee against the annual fee.

Test Your Skills
with our GMP quiz before the tour. All the answers can easily be found with the KEY2GMP™ tool.		 See For Yourself
Take our guided tour through some typical search cases.

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Web Browser: IE 6.0, Mozilla 1.5, Netscape 7
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Stop wasting time debating and searching for GMP interpretations. KEY2GMP™ has incorporated the CGMP regulations, FDA published interpretations, FDA source documents, and related FDA Warning Letters into a single, easy to use search system.

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All GMP Interpretations are supported with FDA published references which include but are not limited to:

  • GMP Preambles

  • FDA Guidelines

  • FDA Compliance Policy Guides

  • FDA Compliance Programs

  • FDA Inspection Guides

  • FDA Human Drug CGMP Notes

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Don’t worry about upgrades or updates. The search service is online so the latest information will always be provided on your screen.

FDA-483 Dispute Support
KEY2GMP™ is an invaluable tool to support FDA-483 disputes during and after an FDA inspection as provided by the FDA-483 dispute program that was finalized in January 2006.

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