Hello Anon,
It seems based on the information provided, if you are tracking these lot numbers internally, they do not necessarily need to be on the kit itself. You might not find anything in regulations for US and Canada for this as general traceability is a general Good Manufacturing Practice (GMP) activity which is left up to Manufacturers for how they apply lot number traceability.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 07-Apr-2023 08:24
From: Anonymous Member
Subject: Label RM lot number tracking
This message was posted by a user wishing to remain anonymous
Hi All,
We receive blank labels on boxes that have raw material lot numbers, we tracked these lot numbers when the labels gets used on a IVD finished kits . Does anyone know if this label lot number need to tracked when they get used on IVD kits? If yes where in the regulation does it say that. We do sell IVD products in US and Canada.
Thank you!