The second draft of GMP Annex 1 is about to be released. The document, a milestone standard for all sterile manufacturers, has been widely revised and extended, with important insights and implementations for the sterility assurance of the finished products. Should all manufacturers get ready to be compliant with the approaching news from Annex 1? The answer is of course “Yes”. Let’s have a look to all the main changes and what they bring for manufacturing companies.