The final draft has 59 pages, which is dramatically longer than the 16-page 2008 version. This revision is a complete rewrite of the annex and was a joint EU, PIC/S, and WHO project, with US FDA personnel actively involved. The new Annex 1 revision must be implemented within one year of its issuance, by August 25, 2023.

The cGMP Annex 1 Workshop will feature industry experts who will provide practical solutions for implementation of the new guidelines at your organisation. These experts were intensely working on commenting and developing solutions for Annex 1 changes throughout the entire seven-year process since the publishing of the first draft of this virtually new guidance. They will provide a unique expertise on the gap issues you may have in your facility regarding Annex 1 implementation and can recommend a viable path forward. Attending this workshop will help your organisation avoid regulatory scrutiny and numerous observations.