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

February 2024

IPEC Federation Position Paper on The Role of Excipients in Determining N-Nitrosamine Risks for Drug Products – version 2

Latest fatal incidents with contaminated medicinal syrup during 2022/2023

August 2023

An updated IPEC Federation position paper

El rol de los excipientes en la determinación de N-nitrosamina – Riesgos para los productos farmacéuticos

March 2022

Spanish version – A new version of this document is available in English

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 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.