PDA Letter Article

PQRI Establishes Thresholds for L&E Identification

by Walter Morris, PDA

Findings Presented at March PQRI Meeting

Members of the Product Quality Research Institute (PQRI) Parenterals and Ophthalmic Drug Products (PODP) Working Group presented the results of their eight-year, multistudy effort to establish threshold limits for the identification of leachables and extractables (L&E) at the 3rd PQRI/FDA Conference on Advancing Product Quality in Rockville, Md., March 22–23.