The Role of Excipients in Determining N-Nitrosamine Risks for Drug Products

March 2022

IPEC Federation Position Paper on The Role of Excipients in Determining N-Nitrosamine Risks for Drug Products

Pharmaceutical Grades of Lactose used in oral preparations is a low-risk excipient

March 2021

IPEC Federation Position Paper on Pharmaceutical Grades of Lactose used in oral preparations

Position Paper on Pharmaceutical Excipients GMP Documents

June 2020

IPEC Federation Position Paper on Pharmaceutical Excipients GMP Documents

Position Paper on Data Integrity for Pharmaceutical Grade Excipients

April 2020

IPEC Federation Position Paper on Data Integrity for Pharmaceutical Grade Excipients

Position Paper on Supply Chain Security of Pharmaceutical Grade Excipients

May 2019

IPEC Federation Position Paper on Supply Chain Security of Pharmaceutical Grade Excipients

Position Paper on Good Manufacturing Practices for Atypical Actives

February 2019

IPEC Federation Position Paper on Good Manufacturing Practices for Atypical Actives

Position Paper on Third Party Audit and Certification Programmes

September 2015

Created in 2010, the IPEC Federation is a global organization that promotes quality in pharmaceutical excipients.

Position Paper on the EU Risk Assessment Guidelines for Excipients

May 2015

IPEC Federation Position Paper on EU Risk Assessment Guidelines for Excipients (2015/C 95/02)