Medical Device Packaging Label Validation

R

RCW

Quite Involved in Discussions
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?
 
Q

QA-Man

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.
 
Y

yodon

Leader
Super Moderator
RCW said:
We did do a 30-second isopropyl alcohol rub test and captured that on video. That was not adequate though.
Click to expand...

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.
 
R

RCW

Quite Involved in Discussions
yodon said:
Interesting... who considered it inadequate and why (because it wasn't a "proper" validation?)?
Click to expand...

Yes, because it wasn't a documented "hold the piece of paper up to the light" validation report.

yodon said:
Was exposure to alcohol what caused the original label to smear?
Click to expand...

No, but moisture was. Sweaty hands moving a box? :confused:

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

Yes, only because no one wants to stand up and say that the emperor is not wearing any clothes!
 
N

NicoleinFlorida

I am thinking something like shipping validation test, or environmental challenging test (moisture as you mentioned).

:2cents:
 
N

narkesteyn

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
 
Y

yodon

Leader
Super Moderator
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?
 
N

narkesteyn

Good morning yodon. Yes the label itself (content, durability, etc.) Thank you.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
M MDR - Packaging - Secondary Medical Device Boxes EU Medical Device Regulations 2
B 510(k) clearance claim on medical device product packaging Other US Medical Device Regulations 6
T Colour of symbols on Medical Device labelling and packaging Other Medical Device Related Standards 1
I Medical Device Packaging Multilingual Labeling EU Medical Device Regulations 3
shimonv GTIN Number on the Packaging of a Serviced Medical Device EU Medical Device Regulations 0
shimonv Is UDI required on the Packaging of a Serviced/Repaired Medical Device? Other US Medical Device Regulations 3
C QR Code on Medical Device Packaging and Notification to Notified Body EU Medical Device Regulations 1
TheMightyWife Address Change - Medical Device Packaging Labelling Requirements EU Medical Device Regulations 7
V Tyvek packaging for Medical device process validation Qualification and Validation (including 21 CFR Part 11) 2
A Medical Device Class 2A, non sterile bodyworn packaging requirements CE Marking (Conformité Européene) / CB Scheme 7
N Medical device non sterile packaging requirement CE Marking (Conformité Européene) / CB Scheme 1
P Secondary packaging operations in medical device facility Manufacturing and Related Processes 1
C Medical Device Packaging Manufacturing - How should product be stored on the pallet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
ScottK Importing medical device for use in fit testing of packaging Other US Medical Device Regulations 3
V Packaging as Medical Device (temperature sensitive products) ISO 13485:2016 - Medical Device Quality Management Systems 6
S Three Questions on Finished Medical Device Traceability, Labeling and Packaging US Food and Drug Administration (FDA) 3
R Regulatory Aspects of Co-Packaging Medical Device and Cosmetic Other Medical Device and Orthopedic Related Topics 6
Q FDA Medical Device Accessory Packaging Requirements US Food and Drug Administration (FDA) 12
J Packaging and User Manual for Medical Device and Accessory CE Marking (Conformité Européene) / CB Scheme 3
N Symbol for Medical Device Sterile Packaging - "Inspect Seal Before Opening" Other Medical Device Related Standards 5
J Labeling Software for Medical Device Product and Packaging Labels for Production Use Other Medical Device Regulations World-Wide 5
J Latex Adhesive Labels used in Medical Device Packaging Other US Medical Device Regulations 7
K Customer Notification Requirements - New Packaging Machine for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 1
J Translation Requirements on Medical Device Packaging Labels ISO 13485:2016 - Medical Device Quality Management Systems 5
E Reference Standard for Shelf Life Testing of Packaging for Sterilized Medical Device Other US Medical Device Regulations 3
P Environmental Control for Storage of Medical Device Packaging Material Other Medical Device Related Standards 8
N Medical Device Secondary Packaging Facility - Regulatory Compliance Requirements? EU Medical Device Regulations 2
ScottK MDD (Medical Device Directive) and Secondary Packaging EU Medical Device Regulations 3
P Reference Material for Medical Device Cleaning and Packaging Manufacturing and Related Processes 1
M Odd Contract Medical Device Manufacturing Situation - Medical Device Packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Sterile Product Ship Testing (Medical Device Packaging) EU Medical Device Regulations 3
D Medical Device Packaging - Trying to learn Technical files EU Medical Device Regulations 4
E "Sales Packaging" contents - Medical Device company Other ISO and International Standards and European Regulations 1
M Checklist for ISO 11607-2:2006 - Medical Device Packaging - Information needed Other Medical Device Related Standards 9
P Is there a requirement for country of origin on packaging of class 2a medical device? Other Medical Device and Orthopedic Related Topics 17
S Relevant Packaging Standards for Medical Device Package testing ISO 13485:2016 - Medical Device Quality Management Systems 10
S Packaging Instruction and BOM Control - Manufacturer of a medical device Document Control Systems, Procedures, Forms and Templates 11
N Regulations for Medical Device in Jamaica Other US Medical Device Regulations 0
M Classification of device according to China medical device regulations China Medical Device Regulations 3
adztesla Design change and Process change Class 3 medical device Medical Device and FDA Regulations and Standards News 2
M Importing a custom component for our medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
adztesla Adding new supplier/ Medical device design change ISO 13485:2016 - Medical Device Quality Management Systems 2
adztesla Medical device Drawing related change justification Other Medical Device Related Standards 0
O Medical Device With 2 Power Cords IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
Stoic Which medical device companies are using Recombinant Factor C (rFC) instead of Limulus Amebocyte Lysate (LAL) for endotoxin testing? Sustainability, Green Initiatives and Ecology 0
I Commercializing a non medical device software Medical Information Technology, Medical Software and Health Informatics 10
I Non-medical device software Preventive Action and Continuous Improvement 0
C California Prop 65 for medical device labels US Medical Device Regulations 3
adztesla GDP rules- redline drawings in medical device Medical Device and FDA Regulations and Standards News 2

Similar threads

Top Bottom