PDA Letter Article

Joint PDA, IPEC TR Addresses Risk Assessments for Excipients

by Eva M. Urban, CSL Behring and M. Schousboe, Novo Nordisk


PDA’s latest technical report, Technical Report 54-6: Formalized Risk Assessment for Excipients, is a joint initiative between PDA and the IPEC Federation. This technical report provides guidance on quality risk management (QRM) principles that can be used to assess the risks to the quality, safety and function of an excipient in a drug product. The Technical Report provides practical guidance to be used in conjunction with existing regulatory and industry standards.