Radiopharmaceuticals account for many lifesaving diagnostic and therapeutic drug products in the market. These drug products, radioligand therapies (RLTs) in particular, represent a relatively novel modality and present multiple, unique challenges to manufacture, release, ship, and administer.

ASTM E2500, issued in 2007, has been the primary standard guide defining what is required to apply quality risk management (QRM) to achieve the qualification of facilities, systems, and equipment in support of validation and process validation. A major update was undertaken in 2024 to better align the guide with current regulatory and industry guidance and current best practice.

From 20–22 April 2026, the 2026 ISPE Europe Annual Conference will bring pharmaceutical and biopharmaceutical professionals to Copenhagen, Denmark, for three days of focused discussion on the challenges shaping the future of regulated manufacturing.