Environmental Monitoring Copy Paste Execute - Lachman Blog

Environmental Monitoring: Copy, Paste, Execute?

No, please don’t. Environmental Monitoring (EM) program is not a “one size fits all” package. Rather, it should be customized to a particular manufacturing space and the processes used after a robust risk assessment that considers potential failure modes and then followed up, periodically evaluating past EM data. If you were to do an internet […]

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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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