Key2Compliance® - Booklets, Updating policy and

Booklets, Updating policy and current revisions

Updating policy

Principles
As some updates (primarily FDA) can be changed or withdrawn on short notice before they are coming into operation, we never update regulatory texts or guides before the actual date they are in operation.

Smaller updates that are not affecting the actual regulatory meaning (as changed addresses or similar information), do not give rise to a new revision of a booklet. This kind of information will be updated in the next revision.

Revision dates and update sources
US FDA and the European Commission handles updates differently.

FDA continously updates Title 21 of the “CFR, Code of Federal Regulations” and publish the updates/changes in the “Federal Register/FR”.

Every year, April 1, “GPO” (the U.S. Government Printing Office) updates the CFR texts with all changes. This information is normally published in May/June the same year.
The revision date stated in the booklets is:
- The yearly GPO update used, or
- Date of the last update published in FR used,
whichever is most recent.

Note. The FR publishing dates, volumes and pages are stated in the end of each updated paragraph.

The European Commission normally makes a revision by Guideline chapter and the new version is published on the Eudralex web site.
The revision date stated in the booklets is when the latest updated chapter included was coming into operation.

Current revisions

» Multi GMP Booklet in english

• 21 CFR Part 210 (Rev Sept 15 2008)
• 21 CFR Part 211 (Rev April 1 2008)
• 21 CFR Part 11 (Rev April 1 2008)
• EU GMP guideline, Part I, Ch. 1-9 (Rev July 1 2008)
• EU GMP guideline, Part II (Rev October 2005)

» Français

» 21 CFR Part 210 et 211 (Rev April 1 2006)

» 21 CFR Part 820 (Rev April 1 2006)

» EU GMP guide, Part I, Ch. 1-9 (Rev July 2008)

» Svenska

» 21 CFR Part 210, 211 och 11 (Rev April 1 2006)

» 21 CFR Part 820 och 11 (Rev April 1 2006)

» EU GMP guide Part I (Rev July 2008)

» EU GMP guide, Part II (Rev October 2005)

» Dansk

» EU GMP guide, Part I (Rev July 2008)

» EU GMP guide, Part II (Rev October 2005)

Note. New versions of the 21 CFR 210 and 211
(effective date Dec 8 2008) will be ready for
delivery early January 2009.

Lundén/Ellow ab and EuroGMP AB • Tjädervägen 10 • SE-181 56 Lidingö • SWEDEN • Phone: +46-(0)8-544 811 60 • e-mail: info@key2compliance.com