Rumours persist that the Annex 1 Update is imminent.
We asked our close colleague Steve Ward, who is the MD of sister company Validair Diamond Scientific if the much-anticipated update to EU GMP Annex 1 really is imminent. Steve is secretary of the Contamination Control Network and deputy chair of the LBI/30 Cleanroom Technology Committee (BSI). Here’s what he says...
"Propositions about the timing of the release, along with learned perspectives and some speculation about the content of the Update are certainly occupying plenty of media space right now."
Annex 1 was last revised in 2008, while the review and consultation process for this next revision began in 2015. So for now, we have little to add that hasn’t already been said, other than confirming from our own professional insight that the new release is imminent. What is worth pointing out is that the Contamination Control Network (CCN) has just published a short brief on the Annex 1 update. Have a read of this informative article.