Labeling template on QMS - Kitting and labeling documentation

[CPhelan]

Hello,
We are heading into a first in human clinical trial this year and I am getting all of the kitting and labeling documentation together.

I have the label created and uploaded the template onto our electronic QMS, though it is not yet released and still in a collaboration phase.

There is still some information I'm missing form some of the kitting labels however is it best practice to upload and approve a template to be used for the device and packaging labels. Then when making the actual label for a specific lot with a specific expiration date would you download the template create your label, save a copy of the label and go through a labeling check list to verify all of the necessary information is on the label?

I just don't think I should have all of the final information on the label thats uploaded to the QMS but maybe the label should be approved and released but I can't see how this would be practical.

I just wanted to ask what was best practice with other companies.

Any advice is greatly appreciated.

 

[Ronen E]

If you have labels with variable fields, your base label (fixed fields) should be reviewed and approved in your QMS, then every instance formally proofed and released for use, and a record kept as part of the lot's DHR (batch record). And of course all this process needs to be captured in a formally approved SOP / WI.

 

[CPhelan]

If you have labels with variable fields, your base label (fixed fields) should be reviewed and approved in your QMS, then every instance formally proofed and released for use, and a record kept as part of the lot's DHR (batch record). And of course all this process needs to be captured in a formally approved SOP / WI.

Thank you Ronen.

 

[Steven Severt]

What format do you typically make your labels in? I'm currently working on my first UDI label as part of a 510k submission, and my client is wanting me to make some CAD diagrams of the labeling. I'm not sure if he wants them modeled in CAD for the purpose of updating the information, like you're talking about here, or if the CAD files are used for label printing? When I saw your post about updating labels I figured I'd ask what format you typically make them and control them in your QMS. It sounds like they want me to export the CAD files as PDFs for their submission, so I'm pretty confused about the purpose if they already have the templates in a Word document.

 

[Ronen E]

"CAD" is very general. It would help understanding if you could please specify what kind of software you are referring to. Thanks.

 

[Steven Severt]

"CAD" is very general. It would help understanding if you could please specify what kind of software you are referring to. Thanks.

I use Onshape to make solid models (similar to SolidWorks). I never send him any solid models but can export in any of the typical formats. I use that to make my drawings and typically export as a .dwg and .pdf for the client. But we’re usually creating the engineering information for the devices in the DHF. He asked for ‘engineering diagrams’ similar to what I send him as a .pdf of drawings that I create in Onshape from my models. I’m not really sure what he’s looking for. I tried to inquire a bit, but he just asked that I do what I’ve been doing for the drawings of the devices. I’m trying to understand what he’s looking for so I can deliver what he needs, and I was wondering what is normal for UDI files to try to point me in the right direction.

 

[CPhelan]

What format do you typically make your labels in? I'm currently working on my first UDI label as part of a 510k submission, and my client is wanting me to make some CAD diagrams of the labeling. I'm not sure if he wants them modeled in CAD for the purpose of updating the information, like you're talking about here, or if the CAD files are used for label printing? When I saw your post about updating labels I figured I'd ask what format you typically make them and control them in your QMS. It sounds like they want me to export the CAD files as PDFs for their submission, so I'm pretty confused about the purpose if they already have the templates in a Word document.

Hi Stephen we are going into FIH trials so just getting our labels ready for that. We are currently just completing the initial draft in Word or Powerpoint just to get the general layout and proposed colors.

I have completed the draft labels in Adobe Illustrator. Very intuitive, can select bleed distance if getting labels printed by a third party they will request bleed for the label. I personally found Adobe Illustrator good to work with. Ensure you download the necessary label symbols from ISO store from 15223-01. These are the internationally recognized symbols for labeling. When you download the labels from ISO store you get the option to download the label as an .ai file which is specifically meant for Adobe Illustrator. Converts to high quality PDFs

 

[Ronen E]

I use Onshape to make solid models (similar to SolidWorks). I never send him any solid models but can export in any of the typical formats. I use that to make my drawings and typically export as a .dwg and .pdf for the client. But we’re usually creating the engineering information for the devices in the DHF. He asked for ‘engineering diagrams’ similar to what I send him as a .pdf of drawings that I create in Onshape from my models. I’m not really sure what he’s looking for. I tried to inquire a bit, but he just asked that I do what I’ve been doing for the drawings of the devices. I’m trying to understand what he’s looking for so I can deliver what he needs, and I was wondering what is normal for UDI files to try to point me in the right direction.

Thanks for explaining.
That's quite confusing actually. As a mechanical engineer who has used SolidWorks extensively, I can't quite understand why would one use solid models for labelling...? If the output needs to be PDF (or even DWG) there are simpler ways to do it.
This is unrelated to creating solid models and drawings of the device itself.
Perhaps what your client means by "engineering diagrams" is the label artwork in a formal drawing title block, with all the relevant information (fields and notes) + dimensions.
There are purpose built tools for generating compliant UDI barcodes (that's what I initially thought you were referring to in "CAD").

 

[Steven Severt]

Ensure you download the necessary label symbols from ISO store from 15223-01. These are the internationally recognized symbols for labeling. When you download the labels from ISO store you get the option to download the label as an .ai file which is specifically meant for Adobe Illustrator. Converts to high quality PDFs

That's definitely something I was wondering about. A different consultant made the proposed labels and sent them to the client, who then sent them to me in a Word document. They had all of these symbols in them and I had no idea where they came from. I appreciate that feedback.

 

[Steven Severt]

Perhaps what your client means by "engineering diagrams" is the label artwork in a formal drawing title block, with all the relevant information (fields and notes) + dimensions.
There are purpose built tools for generating compliant UDI barcodes (that's what I initially thought you were referring to in "CAD").

Well at least I'm not the only one scratching my head trying to figure out what he's looking for. I appreciate your feedback. I think he pretty much is just talking about a PDF drawing with title block and dimensions, so I'm looking at this morning and seeing if I can just snip all of the info from the Word document that he's already sent and throw some dimensions on it and a title block.