The EU Directorate-General for Health and Food Safety has today announced the latest revision of GMP Annex 1.

This extensive revision of the guidelines has a deadline for compliance of 25th August 2023, except for point 8.123 which has a deadline of 25th August 2024. This point deals with the frequency of sterilisation of lyophilizers.

Today's announcement represents the firing of the starting gun for Annex 1 compliance. Many organisations have sensibly been playing a waiting game to see exactly what the new guidelines would say, and when they would come into force. Those questions have now been answered and now is the time to act.

Many organisations will need to make changes to meet the new standard. In anticipation of this change, we've developed a range of products for cleanrooms, RABS, and isolators. Our entire range of products is Annex 1 compliant, from our ImpactAir range of desktop and portable systems to our ISO-CON systems developed for use in RABS (Reduced Access Barrier Systems) and isolators.

Alongside great products which are Annex 1 compliant, we have a team of experts ready to share our knowledge and experience with those facing a challenge with Annex1 compliance. 

If this sounds like you, or if you just want to understand more about Annex 1 and the changes it will bring to your origination, please contact us

For a great summary of the things you need to know about Annex 1, download our infographic here.

For those who want to read the detail for themselves, the latest revision of the Annex 1 guidelines can be found here.