Hi everyone,
I would like to initiate a discussion on the topic of model updates, specifically the updates of chemometric models for quantitative NIR (Near-Infrared) methods used in assay determination for finished drug products. I am aware that both the FDA and EMA have published guidelines on handling post-approval changes to NIR models, particularly focusing on how to document these changes within the company's Quality Management System (QMS) or through different reporting mechanisms to the FDA and EMA.
However, in my experience, our regulatory affairs department tends to take a conservative approach and finds it challenging to modify anything that has been detailed in the original submission.
I’m interested in hearing about your experiences and viewpoints on this subject. How does your organization handle post-approval model updates? What strategies or best practices have you found effective in navigating regulatory requirements?
Looking forward to a fruitful discussion.
Best regards,
Erik