|
|
Article: The IPEC-Americas excipient master file guide
- Article from:
- Pharmaceutical Technology
- Article date:
- June 1, 2002
- Author:
CopyrightCopyright Advanstar Communications, Inc. Jun 2002. Provided by ProQuest LLC. (Hide copyright information)
|
The International Pharmaceutical Excipients Council (IPEC) is developing a global master file guide to meet the need to submit confidential excipient information. The initial focus of the guide is to assist in the improvement of the drug master file system in the United States; however, the intent is to eventually develop a global guide. The format will be coordinated and harmonized with the electronic ICH common technical document for presenting chemistry, manufacturing, and controls as well as safety information.
Currently the only drug master file (DMF) systems that exist to handle the submission of confidential excipient information to support drug applications are in the United States ...