Annex 1: A Guide to EMA’s New Sterile Product Manufacturing Requirements
Summary: In 2023, all pharmaceutical companies that produce sterile products are subject to comply with revisions to the EU GMP Annex 1: “Manufacture of Sterile Medicinal Products.” With an increased emphasis on risk management and contamination control strategies, these new EMA requirements have prompted questions across the industry about manufacturing and technology preparedness. Watch this expert panel, held in conjunction with EUROBIO’23.