Revised Excipient Information Package Guidance Now Published!
The 2013 Excipient Information Package (EIP) User Guide is now available for free download from the IPEC-Americas website. The revised guide updates the originally published 2005 version and can be used by excipient suppliers to provide a standardized set of documents to exchange data between suppliers and their customers.
The Excipient Information Package (EIP) is set up similar to a Material Safety Data Sheet (MSDS) with designated sections to include specified data on specific topics. The guide is intended to assist individuals experienced in evaluating excipient suppliers but is not a replacement for audits.
The IPEC-Americas Regulatory Reference page, located on the IPEC-Americas website, contains links to the specific regulatory references applicable in different regions to provide additional guidance on specific topics.
Usage of the EIP documents can help streamline information and data in a simple formalized and consistent manner to reduce the volume of questionnaires and surveys needed to obtain similar information from multiple customers.
Visit the IPEC Store to register as a user and download the guide. Members can log in to the site and access all the guidance documents directly by clicking here.