06. May 2015

http://ipecamericas.org/content/ipec-federation-publishes-position-paper-eu-risk-assessment-guidelines-excipients-2015c-9502

23. April 2015

Issues related to inaccurate and incomplete information on excipients referenced in the U.S. FDA Inactive Ingredient Database (IID) and FDA policies and guidance related to the review of inactive ingredients in ANDAs continue to create confusion for the pharmaceutical industry. As a result, pharmaceutical companies filing drug applications have encountered longer review cycles, unnecessary requests for additional safety studies/information and/or Refuse to Receive letters from the Agency....

01. April 2015

IPEC-Americas Position Paper Implementation of the NSF/IPEC/ANSI 363 – 2014 Excipient GMP Standard The American National Standards Institute (ANSI) excipient Good Manufacturing Practices standard NSF/IPEC/ANSI 363-2014 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients (NSF/IPEC 363) was approved December 2014 and, since then, has been available for implementation. This paper describes the position of IPEC-Americas on implementation by excipient manufacturers, and use in GMP...