Arlington, Virginia (20-May-2018)
IPEC-Americas Publishes U.S. Drug Master File Guide for Pharmaceutical Excipients (DOWNLOAD)
IPEC-Americas has published the first revision of their U.S. Drug Master File Guide for Pharmaceutical Excipients. The revised voluntary guide offers best practices related to submission of an excipient drug master file utilizing the ICH Common Technical Document (CTD) format.
The Guide provides excipient manufacturers with information pertaining to the United States Drug Master File (DMF) system and excipient DMF submission process. In addition, it contains information for a DMF holder to consider including in an excipient Master File along with assistance to help determine what excipient information might be relevant. The main focus of the Guide is U.S. Type IV (excipient) DMF content, format, filing, and review.
The Guide is available for download at no charge to both IPEC-Americas members and non-members (after registering) by visiting the Document Depot on the IPEC-Americas website at www.ipecamericas.org.
An IPEC-Americas webinar highlighting the Guide content is being planned for later this summer. For more information about the webinar, click here: http://ipecamericas.org/excipient-learning-lab/webinars
IPEC-Americas is the industry association that develops, implements, and promotes global use of appropriate quality, safety, and functionality standards for pharmaceutical excipients and excipient delivery systems. IPEC-Americas, along with its counterparts in Europe, China, Japan, and India serves as a primary international resource on excipients for its members, governments, and public audiences.
For additional information and technical inquiries in the U.S., contact: firstname.lastname@example.org