Medical Device Packaging Label Validation

RCW

Quite Involved in Discussions
#1
My company was issued a corrective action from our customer due to the label on the outside shipping box was smeared and illegible. The medical device is packed one unit per box. Four of these boxes go inside the outer box that had the smeared label. I agree the label used on the outside box was originally a poor choice (not mine though) and the replacement label we are planning to use will withstand a lot more abuse.

In response to the corrective action, my customer is asking that validation of the label be performed and a complete validation report written. If this had been the label on the actual medical device I would agree with this request. HOWEVER, this is the outside box label and a validation report sounds excessive.

We did do a 30-second isopropyl alcohol rub test and captured that on video. That was not adequate though. The ironic thing is though that if I cave in and write a report, it will essentially be an explanation of what was shown in the video.

Do you feel a validation report is required for this situation?
 
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QA-Man

Involved In Discussions
#2
Things can get excessive when you have a customer to please.

I think validating that the label can stay intact and remain legible under customary conditions (21CFR820.120(a)) is not unreasonable. Depends upon how the outer box is being used by the customer (think inventory) and if the conditions which caused the issue were customary.

If you don't want to do a validation study go the verification route; you could offer to do the alcohol wipe test with each lot or order (or have label supplier do it if applicable). This is what's commonly done in the pharmaceutical printing industry.
 

yodon

Staff member
Super Moderator
#4
We did do a 30-second isopropyl alcohol rub test and captured that on video. That was not adequate though.
Interesting... who considered it inadequate and why (because it wasn't a "proper" validation?)? Was exposure to alcohol what caused the original label to smear?

Does seem a bit excessive for a shipping label but, as QA-Man said, you sometimes have to bend to the customer's will.
 

RCW

Quite Involved in Discussions
#5
Interesting... who considered it inadequate and why (because it wasn't a "proper" validation?)?
Yes, because it wasn't a documented "hold the piece of paper up to the light" validation report.

Was exposure to alcohol what caused the original label to smear?
No, but moisture was. Sweaty hands moving a box? :confused:

Does seem a bit excessive for a shipping label but, as QA-Man said, you sometimes have to bend to the customer's will.
Yes, only because no one wants to stand up and say that the emperor is not wearing any clothes!
 
#7
Hi I am new here and this is my first post. Does anyone have a sample Medical Device Packaging Label Validation IQ / OQ validation protocol for this topic that they can post here?

Thanks,
Nick
 

yodon

Staff member
Super Moderator
#8
Not completely sure what you're asking. Are you asking about validation of the label itself (content, durability, etc.) or a label application system or software to develop label content or...? Can you clarify?
 
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