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As some updates (primarily FDA) can be changed or withdrawn on short notice before they are coming into operation, we never update regulatory texts or guides before the actual date they are in operation.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

US FDA

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 1st, "GPO" (the U.S. Government Printing Office) publish all the the CFR texts whether it has been any changes or not. This information is normally not available at the GPO web site until 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 in the booklets.

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

Current revisions

  » English

• 21 CFR Part 210 (Rev Sep 15 2008)
• 21 CFR Part 211 (Rev Dec 8 2008)
• 21 CFR Part 11 (Rev Apr 1 2008)
• 21 CFR Part 820 (ebook only) (Rev Apr 22 2010)
• EU GMP guideline, Part I, Ch 1-9 (Rev June 30 2011)
• EU GMP guideline, Part II (Rev 31 July 2010)

  » Français

» 21 CFR Part 210 et 211(Rev Sep 15 / Dec 8, 2008)

» 21 CFR Part 820 (Rev Apr 1 2006)
Note. Une modification d'une adresse de contact dans 820.1 (e) a été réalisée le 22 avril 2010 mais nous n'allons pas mettre à jour ce jusqu'à la prochaine impression.

» EU GMP guide, Part I, Ch. 1-9 (Rev June 30 2011)

» EU GMP guide, Part II (Rev July 30 2010)

  » Svenska

» 21 CFR Part 210, 211 och 11(Rev Sep 15 / Dec 8 / Apr 1, 2008)

» 21 CFR Part 820 och 11 (Rev Apr 1 2006)
OBS! En ändring av en kontaktadress i 820.1(e) genomfördes 22 april 2010 men vi kommer ej uppdatera detta förrän vid nästa tryckning.

» EU GMP guide Part I (Rev June 30 2011)

» EU GMP guide, Part II (July 31 2010)

  » Dansk

» EU GMP guide, Part I (Rev June 30 2011)

» EU GMP guide, Part II (Rev July 312010)

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