Since 2015, the EMEA has been working on the revision of Annex 1 of Volume 4 of Eudralex, which deals with the manufacture of sterile medicinal products. This revision was under call for comments until July 2020.
To date, there are no details on when and how the revision will be implemented, however operators are starting to prepare for its arrival.
In this video, an expert presents a field experience of how to implement improvements in order to meet the requirements.
This webinar was given in French by Jean-François Meurisse accompanied by Gabriel Aubault.
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