The much-discussed revision to the EU GMP Annex 1 is expected to be published early this year, bringing some major changes to drug developers’ current process and manufacturing methods for sterile products. Although the draft revision has been widely shared and commented on, it is still unclear the total impact this document may have across regulated industries. Here to share their perspective on the Annex 1 Revision document is Patrick Nieuwenhuizen from PharmaLex.

About Our Guest:

Patrick Nieuwenhuizen, Director, Senior Consultant with PharmaLex Ireland

Patrick is an experienced Quality professional with a Microbiology & Sterile Manufacturing background amassing expertise over the past 25 years in the Pharmaceutical Industry. Patrick has worked for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Lyo and Fill Finish, Vaccines, and Solid Oral Dose. He is also a qualified lead auditor and SME in Quality Control, Sterility Assurance, New Facility Design/Upgrade, and risk facilitator for Quality Risk Management.

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