More than two years have passed since the publication of the new version draft of Annex 1 EU GMP vol. 4. We all agree that this new revision provides significantly more detailed requirements regarding sterile manufacturing.
One of the most challenging issues is the new approach to Environmental Monitoring (EM) of our facilities, based on a Risk Management strategy. The new draft requires us to define and optimize all the parameters that compose the monitoring plan; one of the new requirements is to define the exact location and the number of sampling points needed to perform a correct EM, always under the perspective of the risk-based approach.