The European Commission published the long-awaited draft of Annex 1 “Manufacture of Sterile Medicinal Products” in December 2017. PDA is currently working with a team of 15 volunteers to comment on this document.

Hal Baseman, Chief Operations Officer, ValSource, and Gabriele Gori, Vice President Audit and Risk Management – Global Quality, GSK Vaccines, are leading this team. Both also served as co-chairs for five workshops on Annex 1 PDA sponsored in the United States and Europe in 2016 and 2017. Jahanvi (Janie) Miller can be contacted for any further details. A session at the 2018 PDA Sterile Medicinal Products Manufacturing Conference will review PDA’s comments. Register to attend.