Since August 2023, the new Annex 1 is effective in a revised version, with a transition period until 2024. While the basic structure remains the same, the addition of extra subchapters has made the Annex more comprehensive and detailed. The focus is particularly on the production of sterile products to minimize the risk of microbiological, particulate, and pyrogenic contamination. Additionally, the new Annex 1 serves as a guide for the best possible protection of sterile products.