EU GMP Annex 1 "Manufacture of Sterile Medicinal Products"

After more than five years and two public drafts for comment, the European Commission published the final version of the new EU GMP Annex 1 "Manufacture of Sterile Medicinal Products" on August 25, 2022.

At the Annex 1 – Aseptic Conference as part of this year's aseptikon on September 20/21, 2022 in Mannheim, you will learn firsthand:

– what consequences the new Annex 1 has for aseptic manufacturing,
– how the authorities interpret the new requirements,
– how the pharmaceutical industry assesses the new Annex 1,
– how it influences current technological developments in aseptic manufacturing, and
– you will learn about current case studies and implementation examples from aseptic production.

Discuss your questions directly with the following inspectors and colleagues:

– Dr. Simone Biel, Merck
– Dr. Rainer Gnibl, Government of Upper Bavaria
– Stephan Löw, CSL Behring
– Barbara Moser, CSL Behring
– Luigi Scaffidi, Boehringer Ingelheim Pharma
– Dr. Franz Schönfeld, Government of Upper Franconia
– Dr. Frank Sielaff, Darmstadt Regional Council
– Hans Steier, Vetter Pharma-Fertigung
– Patrizia Wagner, Vetter Pharma-Fertigung
– Dr. Ingrid Walther, Pharma Consulting Walther
– Dr. Florian Witte, Boehringer Ingelheim Pharma
– Jörg Zimmermann, Vetter Pharma-Fertigung