Hi
Personally I would suggest:
"B.II.b.3 Change in the manufacturing process of the finished product, including an intermediate used in the manufacture of the finished product"
And try to decide which (if any) of the categories are closest to the proposed (non-routine) process change and product type. i.e. in my mind this is a process change since re-processing will be occur under certain circumstances.
As an aside - if a Type 1A category is close but you cannot fulfil all the conditions then you could propose it as a "Type 1B by default" provided it could not "have a significant impact on the quality, safety or efficacy of the medicinal product" and is not specifically listed as a Type II change. (And was not in a previous recommendation).
Alexis
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Alexis Cockroft
Lex Regulatory Ltd
Royston
United Kingdom
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Original Message:
Sent: 13-Mar-2024 16:48
From: Anonymous Member
Subject: Reprocessing of Final Filtration and Fill step
This message was posted by a user wishing to remain anonymous
Hi RAPS member/ experts,
I wanted to learn, if there is an EU guidance that lists the "Conditions to be met" and "Documentation to be supplied" for introducing a reprocessing step for final filtration and fill.
Eudralex guidance on variations doesn't have clear information and category for reprocessing.
Thank you in advance.