Change Is Coming to Good Distribution Practices: Can You Help?
The U.S. Pharmacopeia is asking for your help as it revises its guidance on Good Distribution Practices.
In the June 23 Webcast, “USP General Chapter (GC) <1083> Good Distribution Practices—One Global Document Under Consideration,” Mary G. Foster, PharmD, Chair of the USP Expert Committee on Packaging, Storage, and Distribution, told the audience that the committee is preparing General Chapter <1083> Good Distribution Practices (GDPs), which when final will replace two official USP General Chapters on GDP: 1) on drugs, <1079> ; and, 2) <1197> for excipients.
The USP has been working on GDPs for the last 10 years, and most recently began discussion with the World Health Organization and the European Medicines Agency in an effort to create one standard document and approach to distribution practices globally. The initial discussions began in October 2014 and are intended to include the US FDA, Health Canada, and other regulatory bodies. Each country would maintain their own regulatory guideline but could use a GDP standard as the focal point, Foster tells PMP News.