Updated: Questionnaire for Excipient Nitrosamines Risk Evaluation

Category: IPEC Europe
  • 15 Mar 2021

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IPEC Europe announces the availability of its revised “Questionnaire for Excipient Nitrosamines Risk Evaluation” (version 3).

First published in December 2019, this form has proven useful to excipient producers and MAHs alike. As before, its aim is to assist excipient manufacturers collect data in a standardised format that drug product manufacturers need to perform their nitrosamine risk assessments.

This version includes 2020 regulatory updates, referencing the EMA assessment report “Nitrosamine impurities in human medicinal products” and related “Q&As”, as well as US FDA Guidance for Industry “Control of Nitrosamine Impurities in Human Drugs”. Hopefully, the same information will assist in answering questions from other regulatory agencies, too.

New features are a matrix to help filter which sections need to be completed based on the structure and the origin of the excipient, and an optional conclusion.

A comparison Questionnaire in PDF format, highlights the changes made in the new version.

Update (1 March 2022) : IPEC Federation has published a Position Paper on the Role of Excipients in Determining N-Nitrosamine Risks for Drug Products.

Update (21 February 2023): A new version of the questionnaire is now available - click here


For comments, please contact the IPEC Europe Secretariat : info@ipec-europe.org