Current Edition

PDA Europe Annex 1 Workshop

The Pharmaceutical world and those involved with the manufacture of sterile products are anxiously looking out for the publication of the final approved revision of EudraLex Annex 1 “Manufacture of Sterile Products. Organisations must prepare themselves based on the text of Draft Revision 12 which was published in February 2020. In support of preparation, PDA organised several workshops using the publicised Revision 12 as a reference point. The 2022 PDA Annex 1 Workshop held on 16 & 17 May in Dublin was the second of a series of four and the first one on European soil. Delegates had the opportunity to discuss their interpretation, challenges and possible solutions with peers from the industry. Patrick Nieuwenhuizen, Director Senior Consultant at PharmaLex, summarises the main takeaways from this forum.