Label verification and validation

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#1
We sell a wearable class II device that monitors the users temperature. The patch itself has a label, its pouch that contains it has a label and the retail packaging has a label. Do all 3 labels need to be verified or validated?
 
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yodon

Staff member
Super Moderator
#2
Not completely sure what you're asking.

Label content is often established as requirements / specifications and then the artwork could be verified to meet the requirements.

Labels must stand up to conditions to which they are exposed so there's a validation aspect there (maybe not so much for the retail pkg label).

Depending on how the labeling is done, there would be some assessment; e.g., if purchased pre-printed, receiving would confirm the printed labels meet spec; or if printed in manufacturing, there should be an assessment that the labels are correct (not to mention validation of any label design or printer software). These could also include physical confirmation that barcodes are readable and contain necessary info.

Since we're talking FDA here, do take a look at 820.120 for some additional specifics.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#3
We print bar code labels at various stages of production. Some of the actual product, some on the final packaging. Does each printed bar code label require validation/verification?
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#5
The FDA considers just one label to be the product label, right? The one immediate to using the device? The rest is labelling?
 

indubioush

Quite Involved in Discussions
#6
Yes. FDA has "label" and "labeling." You could have more than one "label" and more than one article of "labeling." The "label" is the one that contains all the required regulatory information.
 
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