UDI Label Verification - How do we ensure the barcode is correct and prove it?

cabjerk

Starting to get Involved
#1
Hello,

From the FDA view point "how do you ensure that barcode will print out correct each and every time?" Our systems have been validated, but how do we ensure the barcode is correct and prove it?

If this has been asked before please send me the link. Did a search and could not find anything.

Any feedback on this will be great?

Thank you,
 
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Mark Meer

Trusted Information Resource
#2
Here are links to few previous threads:

UDI (Unique Device Identification) Verification Requirements



820.120 UDI (Unique Device Identification) Labeling Verification Requirements


UDI (barcode, datamatrix) Verification Solutions

As I recall, there was no consensus, other than that the safest (and, of course, most expensive) option is to invest in some sort of automated equipment. Every single barcode need not necessarily be checked, but perhaps the first and last off a batch might be a suggestion, depending on product/volume/capabilities...

MM.
 
Last edited:

JJLit

Starting to get Involved
#3
The direction that we took was to buy a calibrated verification unit. For our purposes, scanning each barcode works very well. The unit produces a report with the barcode quality grade. You can automate these units in any way that you want.
 

Haddad9921

Starting to get Involved
#4
Hi,
I don't know if this is the right place to ask this question. I am looking for a barcode challenging procedure to test for accuracy of readability. This is a requirement for food packaging manufacturers. Let me know if you have one you can share or if you can direct me to where I can find one.
Thank you
 

Mark Meer

Trusted Information Resource
#5
Suggest checking the links to other threads I posted previously here (Post #2), where this has been discussed.

I'd attempted to justify a more simplified procedure that does not involve specialized equipment...but I think the general consensus is that some sort of dedicated barcode verification equipment/scanner is necessary. How often you want to verify is up to you. You can setup an automated system that checks every label off the production line, or setup a system of spot-checking (for example, maybe the first and last label for every batch).
 
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