Reply To: Over-labeling for Lot Number


Neil Armstrong
Participant

Reply To: Over-labeling for Lot Number

Hi,

I’m curious how this is progressing for you.

Since you need to change the lot number – which is interesting – I would consider handling this as a rework, instead of trying to manage separate modifications.

With such a situation, I would recommend a complete overlabel, specifically reprinting a new ancillary label and cover the original. The critical requirement is that this work must be performed in a properly licensed and GMP-audited facility with clear batch documentation and kit ID management.

Neil