USP plans Revision of General Notices Section of the Pharmacopoeia

Recommendation

7/8 May 2024

EU GMP-/FDA-compliant Sampling - Live Online Training

Proposals for a revision of the general notices section of the USP are published in the Pharmacopeial Forum 39(1) from January/February 2013. These revisions are expected to enter into force on 1 May 2014.

With the switch to online publication of the Pharmacopeial Forum (PF) it is envisaged that the PF is used in the future solely to publish proposed revisions for comment.

Now the accelerated revision of texts that have to be updated and implemented urgently will not be carried out by means of the PF any longer. These so-called "Interim Revision Announcements/IRAs" will not be published in the PF anymore. IRAs now are published only on the USP website, and then incorporated into the next official publication.

Especially interesting is the notice that in future USP-NF will focus on the electronic version since users of USP-NF are increasingly using the online rather than the paper version. In the future, an explicit indication will be included, specifying that in the event of any disparity, the electronic version will be deemed to apply!

There is a whole series of other proposals. For instance the term "official compendium" is now considered critical and a more precise definition of the term is proposed. Further topics are impurities, including "other impurities" and "elemental impurities".

As concerns reference standards it is emphasized explicitly once more that only those results obtained using USP Reference Standards may be deemed to be conclusive.

You can find the detailed article in the PF online version.