The purpose of revising Annex 1 is to reflect the changes that have occurred in the legislation and production of sterile medicinal products since the first edition in 2007. The latest revised version of EU GMP Annex 1 starts from the chapter on isolator systems, specifically proposing the integrity testing of gloves on isolator devices. The new regulations involve the definition of the time intervals for glove testing, thus standardizing the usage criteria for manufacturers. In fact, the first edition of Annex 1 drafted in 2007 stipulated that glove leakage tests must be carried out frequently, but did not provide any further specifications. The newly released revised version precisely fills this gap, stating that for isolators, glove tests must be conducted at specified time intervals, at least at the start and end of each production batch.