Annex 1: A Step Increase in Sterile Manufacturing Requirements

A 300% increase in anything gets attention, however, when it is a “rule governing medicinal product in the European Union” it demands attention and action (EudraLex – Volume 4 (  Annex 1 which is the guide for the “Manufacture of Sterile Medicinal Products” (20220825_gmp-an1_en_0.pdf ( was just released on 22 August 2022.  This document is […]

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