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14th Sep 2023, 01:03 PM
#1
Storage of investigational product and serum samples within the same freezer.
I understand that these boards are not frequented all that much these days (MHRA, it would be good to promote them more).
I'm looking for some good clear guidance and signposting when it comes to regulation on the storage of an investigational product and a pathological product (serum), in the same fridge or freezer.
The CDC in the USA provides some common sense guidance if the storage of both in the same unit is necessary, that they should be separated by bins/containers, and or kept on different shelves, with vaccine for example being kept at the top, and pathological samples kept on the bottom in order to prevent contamination.
This guidance is not easily come by. I can see the CQC notes that food and specimens should not be kept together find the right schedule in any of the legislation I've reviewed to mandate this. Is anyone able to signpost me?
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