The revision of the 2007 version of Annex 1 by the European Commission, which began with the first draft presented in 2017, marked a significant point for the pharmaceutical industry. Initiated upon the recommendation of the GMP/GDP Inspectors Working Group and the PIC/S Committee, which guide the manufacture of sterile medicinal products, this revision aimed to develop an updated regulatory framework to reflect the latest changes in both manufacturing practices and regulatory standards. The new version of Annex 1 (which came into effect in August 2023, was designed to provide clearer instructions for manufacturers , emphasizing the use of advanced tools and a deeper understanding of processes, as outlined in the ICH Q9 and Q10 guidelines. The revision also sought to align Annex 1 with other relevant GMP documents, ensuring consistency and removing uncertainties.