What Annex 1 Means for Sterilization and Moist Steam
In December, the European Union released the long-awaited revision of Annex 1. The goal behind the revision was to reinforce the need for manufacturers to stay current with innovative technologies related to sterile manufacturing. To meet this goal, the revision aims to clarify regulatory requirements, introduce quality risk management (QRM) principles, allow for the inclusion of new technologies and innovative processes, make the structure of the document more logical and remove some ambiguities.
Despite these lofty goals, however, the draft contains several terms and requirements that are not in line with ISO and pharmacopeial recommendations. At the same time, some requirements of the draft Annex 1 differ from U.S. FDA guidelines or even USP recommendations, including those for both biological indicators testing and feed water used to generate pure steam. Such differences may present challenges for global companies as they must comply with the legislative requirements where the product is marketed.