4 replies to this topic

[kpl91]

Hello,

 

I'm hoping that I can get some advise on how to execute an effective label verification process. 

Here is some background information:

We are a small company that produces vitamin supplements only. We hire contract manufacturers to make our products and we are responsible for providing the labels.Our label verification process is very all over the place as of right now. The most difficult stage of the whole process is keeping track of label revisions before the final approved label is sent to the printer. 

Any suggestions on how to make this process simpler or more defined?

How should we track label revisions during the drafting process?

How many people should be reviewing the label before final review and sign off by QA?

Should we incorporate label numbering system with a format that can help those reviewing the label to easily identify what product/ label revision number they are looking at instead of having to look through the label and find what is different from the previous label revision?

 

Any advise would help!

 

Thanks!

[Vinodhini]

Hi,

 

Maintain list of product labels by unique identification number for each with revision number and date in the header of the sheet as like we use for food safety management system documents. Remember to update the current revision number and date in the list and move the "Not in use / old" label to obsolete file (shall be created obsolete folder / file). This is the most appropriate way for control of any kind of documents.

[Ryan M.]

Each label should have it's own unique number.  If you have a system or database for your labels to create the numbers that's fine.  You could also use the UPC number, but...I'm guessing during the development process you typically don't have a UPC code yet?  Or, just make a number for each new label.

 

As another said, keep revision numbers with dates and each label revision.  Archive the old revisions.  Numbering scheme can be simply the unique label number and hypen with revision number afterwards.  Example, "10358230-01" for revision 1.

 

I would have marketing, QA, and operations or technical sign off on the label.  Generally, the more the better.  You should have multiple persons trained on label review procedures and your SOP should identify the primary and the secondary persons for each portion of the review.  The SOP should also described what each person reviewing the label is reviewing, correcting, updating, etc.

[Piddyx]

I will add this to what people have said before.  

When you are working on the labels, don't leave anything in the UPC slot that can be confused with the actual UPC code.  We use a barcode with the word DUMMY on it so that it is never overlooked.

I watermark obsolete over old labels so we would never sign off on the proof of an old label. 

[John_E]

How should we track label revisions during the drafting process?

How many people should be reviewing the label before final review and sign off by QA?

Should we incorporate label numbering system with a format that can help those reviewing the label to easily identify what product/ label revision number they are looking at instead of having to look through the label and find what is different from the previous label revision?

 

I agree with above, make the label specification a controlled document and each specification should have a number and revision number associated with it. I would say no more than 3 should review any document or spec change but the change process should follow any other document revision with a record of what was changed, when, by whom, etc. We manufacture for pharmaceuticals and we only have one sign-off on our spec's by the QA Manager.

 

My other thought is how you verify labels when they come in. Do you have a documented inspection? Do you record the issuance and return of labels with the destruction of unused printed labels for full reconciliation? I would definitely incorporate those items in your label control program.

 

-John