I'm curious, too. The guidance doesn't seem very prescriptive.
https://www.ema.europa.eu/en/documents/comments/overview-comments-received-ich-guideline-q12-technical-and-regulatory-considerations-pharmaceutical-product-lifecycle-management_en.pdf
https://www.fda.gov/files/drugs/published/Process-Validation--General-Principles-and-Practices.pdf
I'd guess it may not be practical to generate a complete Module 3 retroactively for a low-margin product, but over the decades some process control work has probably been done. I wonder how much data may be available to support a risk-based decision.
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Anne LeBlanc
United States
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Original Message:
Sent: 10-May-2024 03:27
From: Raushan Blake
Subject: Assessing changes for a grandfathered product
Hello Armin,
Thank you for the response. For devices, I have understood that there is no such provision under the MDR, how about drugs though?
Regards,
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Raushan Blake
Regulatory Affairs Specialist
Viatris
Inverin, Galway
Ireland
Original Message:
Sent: 09-May-2024 18:57
From: Armin Beck
Subject: Assessing changes for a grandfathered product
For the EU, the MDR does not allow any grandfathering. Your product needs to be always State of the Art
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Armin Beck
CEO
SunTrixConsulting LLC
El Dorado Hills, CA
1-925-212-7683
armin.beck@suntrixmedical.com
Original Message:
Sent: 08-May-2024 10:33
From: Raushan Blake
Subject: Assessing changes for a grandfathered product
Hello,
If there is an old product which does not have all the Modules and only Module 1 is present in the dossier, which is possible for products from 60's or 70's.
How do we assess a change then ? Changes made in manufacturing now would require assessment to look at Module 3, 4, 5 sections, and if they are not present, then how do we assess the regulatory impact of the change ?
Looking forward to hearing from the industry experts.
Regards,
Raushan Blake
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Raushan Blake
Regulatory Affairs Specialist
Viatris
Inverin, Galway
Ireland
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