Control of Medical Device Labels and Labelling Activities - Looking for a procedure

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O

ontheopenroad

#12
Re: Control of Labels and Labelling Activities - Looking for a procedure

qualityalways,

Feel free to private message or e-mail me. I'd be glad to share what we use here. For some reason, certain people like to be difficult on the forum.
 

Coury Ferguson

Moderator here to help
Trusted Information Resource
#13
Re: Control of Labels and Labelling Activities - Looking for a procedure

ontheopenroad said:
qualityalways,

Feel free to private message or e-mail me. I'd be glad to share what we use here. For some reason, certain people like to be difficult on the forum.
That maybe true that sometimes we are being "difficult" but the issue is:

When information/recommendations are being asked, the seeker(s) need to be specific and clear on what they are asking.

Wes's comment:

Wes Bucey said:
Based on the original poster's other posts, that would be good guess. The point is - why should we have to read the poster's mind or guess? What research has the poster done to this date? What were his results? Is he "confused" or just "trying to keep his first source honest?"
There has been times we (Covers), are asked to provide information, recommendations, and opinions on posts that are not specific. So we do sometimes try to read the minds of the poster, or we asked questions for further clarification. This was not being difficult, just clarification of the questions.

It appears that the information you have sought, is provided in Al's post and ontheopenroad, has offered their assistance.
 
G

graymom

#14
Re: Control of Labels and Labelling Activities - Looking for a procedure

Did you ever get an answer? I'm now looking for the same (label procedure). I was specifically wondering what are tolerances that have been set on % yield after production (label reconciliation).
 
G

geno27

#15
Re: Control of Labels and Labelling Activities - Looking for a procedure

what about in-process labeling
 
M

MIREGMGR

#16
Re: Control of Labels and Labelling Activities - Looking for a procedure

I was specifically wondering what are tolerances that have been set on % yield after production (label reconciliation).
Tolerances for label reconciliation, as in an allowable number of labels that you cannot account for?

My understanding is that every label must be accounted for. Tolerance = 0.
 

pbojsen

Involved In Discussions
#18
Labeling procedures include:

1. Line clearance procedures, to ensure you're labeling the product with the correct label and there are no labels left over from the previous job.
2. Label reconciliation - how many labels printed, how many used, how many scrapped or returned to inventory.
3. An example of the labels used on the production order is retained with the DHR. These are normally applied to a label form for that purpose. Includes spaces for signoffs and second party verifications.
4. Depending on the device classification, you could have a label printing specification that has images of the label stock, label template, UPC code, and artwork for that particular product. This should be under change control.

I do have a procedure, but can't share it at this time.
 

HnZul

Starting to get Involved
#19
Labeling procedures include:

1. Line clearance procedures, to ensure you're labeling the product with the correct label and there are no labels left over from the previous job.
2. Label reconciliation - how many labels printed, how many used, how many scrapped or returned to inventory.
3. An example of the labels used on the production order is retained with the DHR. These are normally applied to a label form for that purpose. Includes spaces for signoffs and second party verifications.
4. Depending on the device classification, you could have a label printing specification that has images of the label stock, label template, UPC code, and artwork for that particular product. This should be under change control.

I do have a procedure, but can't share it at this time.
Hi pbojsen, for item #2 label reconciliation, are they a requirement from any regulation?
 
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