3 Things Manufacturers Need to Know About the New Annex 1 Revision

In August 2023, long-awaited drug manufacturing regulations took effect with the implementation of the European Commission’s updated “Manufacture of Sterile Medicinal Products.”

Known as the Annex 1 revision, the updated rules will impact manufacturers across the globe, says Marcia Baroni, VP, Enterprise GxP Compliance & Systems with Emergent. “Some significant change is going to be required for everyone,” says Baroni, who sits on the scientific advisory board of the Parenteral Drug Association (PDA), which provided comments throughout the Annex revising process.

The revision, which was a joint effort among teams from the European Union, Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the World Health Organization, with involvement from the U.S. Food and Drug Administration, was an involved process that took seven years and broadened a 16-page document to 59 pages.

The current regulations are more prescriptive than in the past, says Baroni, and demand more responsibility and accountability from manufacturers. “With the Annex 1 revision, regulators are saying they want employees involved in pharmaceutical manufacturing to have both the experience and demonstrated capability,” she says. “It isn’t good enough to have just read the procedure and know what to do. You have to be able to show that you can do it.” 

As biopharmaceutical organizations around the globe adjust to the new guidelines, Baroni shared insights on three things they need to know about Annex 1.