CRED Getting the CMC Dossier Right 2024

28/08/2024

N -Nitrosamines

Industry Workflow

Industry established risk assessment workfkows for DS and DP

3 elements:

Risk identification

Risk characterisation

Confirmatory testing

https://www.efpia.eu/media/tkbnsicy/efpia-nitrosamines-risk management-workflows-jun-24-udpate.pdf

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Stability Considerations

During development

● Stability data needed to support use period of the API/product during the studies

For registration

● Stability data following ICH Q1 guidelines needs to support API retest period

● Forced degradation studies used to identify potential degradants in order to establish stability indicating analytical methods

● Real time stability establishes the actual degradants (could be complemented by stressed (ASAP) studies)

● Typically need 1 year real time data, but less data can be accepted on case by case if agreed during pre-submission interactions (in such cases, additional data is typically provided during review or as a post approval commitment)

● Region specific requirements (e.g. zone 4)

● Propose post approval stability protocol and justify which attributes will be monitored

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