PDA Letter Article

Regulatory Concerns Drive New Developments in Glass Packaging

by Rebecca Stauffer, PDA

Glass has a long history in parenteral packaging. In fact, for hundreds of years it was the only parenteral package option available. Yet almost ten years ago, the U.S. FDA expressed concerns about recalls due to glass defects, particularly delamination, in the industry advisory “Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs.” Pharmacopeias followed suit, seeking to harmonize their glass chapters.

To get a sense of the current regulatory and compendial climate, the PDA Letter reached out to some of the speakers and planning committee members at the upcoming PDA Parenteral Packaging conference for their perspectives on the current state of glass packaging.

PDA thanks Roger Asselta, Horst Koller and Derek Duncan for their contributions.