FAQ

CFR – Code of Federal Regulations
CPG – Compliance Policy Guides
FR – Federal Register
GFI – Guidance for Industry

Most abbreviations can be found in the “Acronyms and Abbreviations” (Glossary) section.

The Library of documents in Gate2GMP® does only contain final documents with a few exemptions. There are a couple of FDA-documents where we have chosen to include the draft versions since the FDA has no better relevant source for interpretation of that specific subject and have stated that they will not finalize the guide but will maintain it on their website as a draft for reference.

You can search with one or more words.
The result will show documents where the search words are present, both as whole words or as a part of a word (e.g. valid will show both valid, validation, validated etc.)
You can not use search operators as dubbel quotes, question marks or asterisks.

The PDF documents are protected from changes and copying but can be printed in high resolution.

Right-click in the text and choose “Search (Simple)” or Ctrl+F. (The word is highlighted in the text and you can scroll forward/back)
For an advanced search, choose “Edit” > “Advanced search” or Shift+Ctrl+F (The result is presented as a list in the left column.)

No WL:s regarding those paragraphs have been issued since 2006.

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If you have a valid subscription, please contact the Key2Compliance® customer service: info@key2compliance.com

– Select a paragraph from the drop-down list.
– A list of the interpretation documents for this paragraph will appear.
– Click on a document link to open the Interpretation summary.
– Click on the “Open PDF” button to open a printable pdf with the summary and an excerpt from the document. The relevant text in the excerpt is marked in yellow.

We are always happy to expand the glossary. Please send an e-mail with a suggestion and we will consider if it is suitable to add.

Please send an e-mail with the link name and we will fix it asap.

There are several free EPUB reader apps for the most common platforms (Windows, Mac, iOS and Android).
Search in your app store and install on the device where you have downloaded the EPUB file and open it from there.
Recommended apps
Mac or iPhone: iBook (std app)
Android: Moon+ Reader ; eReader Prestigio
Windows: Calibre ; Freda

The EPUB format is adapting to the screen size (free flowing text).
The books have an index with links and a seach function.

We are very greatful for all reports on malfunctions.
Please send an e-mail with a short notice on what is wrong and we will fix it asap.