IPEC Releases Revised Excipient Information Package Guidance - - BioPharm International

ADVERTISEMENT

IPEC Releases Revised Excipient Information Package Guidance


The 2013 Excipient Information Package (EIP) User Guide is now available for free download from the International Pharmaceutical Excipients Council (IPEC)-Americas website. The revised guide updates the 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 EIP is 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 organization reports.

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.

Use 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, according to an IPEC-Americas statement.

 

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

FDA and NIH Win Award for IP Licensing of Meningitis Vaccine
September 26, 2014
FDA Releases First-Ever Purple Book for Biosimilar Characterization
September 26, 2014
FDA Releases REMS Report
September 25, 2014
NIH Funds Tissue Chip for Drug Screening
September 25, 2014
UPS' Pain in the Supply Chain Results
September 23, 2014
Author Guidelines

Click here