Webinar on reflection paper on the qualification of non-mutagenic impurities

• Date:
  Wednesday, 06 May 2026 , 10:00 - 11:30 Amsterdam time (CEST)
• Location:
  Online

Event summary

EMA has published a reflection paper on the qualification of non-mutagenic impurities.

The current version follows the earlier one that was published in 2018 and has been updated considerably. The update focuses on alternative strategies for qualifying novel impurities or qualifying higher levels of impurities that were previously qualified at a lower level.

The aim of the reflection paper is to provide a practical reference for applicants regarding the qualification of novel impurities:

• arising from changed manufacturing processes;
• discovered after safety studies have been concluded;
• when higher levels need to be qualified and existing data from safety studies are not sufficient for qualification.

The objective of this related webinar is to introduce non-clinical and quality assessors to the principles outlined in the reflection paper. This will enable them to use data on the impurity or a robust surrogate to qualify proposed specification limits for non-mutagenic impurities above ICH Q3A and Q3B qualification thresholds.

At the end of the webinar, participants will be able to apply the principles of the reflection paper to qualify specification limits for non-mutagenic impurities. This is done by using metabolism data, performing read-across to the active pharmaceutical ingredient (API) or a surrogate, assessing the level of concern for the impurity, and calculating an acceptable limit (AL).

A video recording will be made available after the event.