Watch for expanded Chapter <1083> topics

摘要

Chapter <1083> Good Distribution Practices (GDPs) is expanding its scope to include APIs, excipients, dietary supplements, and more. Active pharmaceutical ingredients (APIs), excipients, dietary supplements, medical devices, combination products, reagents, solvents, biologicals, and cell and gene therapies are among topics now included in USP's General Chapters on GDPs. These topics, included for the first time, were described in the presentation, "Update on Subjects Becoming Next Sub-Chapters Plus an Overview of Extractables & Leachables from the Transportation Perspective," by Mary Foster, USP Expert Committee Chair, and consultant with The Foster Group, LLC.