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What Annex 1 Means for Sterilization and Moist Steam

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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 (1).