21 CFR Part 820.184 - Label Requirements

[cabjerk]

Per 820.184 The DHR shall include, or refer to the location of, the following information.

(e) "The primary identification label and labeling used for each production unit"

Does this mean you MUST have a copy of each label OR that you can reproduce the label that was on the unit per serial or UDI number? In our software system we can reproduce the exact label per the serial or UDI. But one of our last audits said we MUST have a copy of the label that was on the unit.

Anyone have feedback on this?

Thank you,
Carl

 

[NicoleinFlorida]

I am not very sure that I understand your question. If you mean that your software can create the labels for a previous lot, whether you need to maintain a copy of the labels. I think you still need to save the copies.

In my case, we maintain DHR electronically that include copies of labels of each lot/batch. After create the UDI and labeling stickers, I save these as PDFs , and then compile with other DHR records.

 

[cabjerk]

Yes, our software can re-create a label based on the serial number/UDI sales order. We were told we needed a copy (pdf/picture/real copy) of the label that is on the device. I'm just getting feedback as to which way meets the requirements.

 

[NicoleinFlorida]

According to 820.184, the DHR shall maintain the label copies or refer to the location of the labels. Since the software will re-create not maintain that label, I don't think the software is the "Location“ your DHR will refer to.

 

[cabjerk]

In the 820.184 it does not say "copy". Please see the attachment.

 

[yodon]

I think the intent of the requirement is to be able to prove that you put out labels containing all the required and correct information. So I don't think that re-creating the label from the software would meet the intent. If you stored the actual image (not just the data to re-create the label) and had proper controls (part 11) for maintaining that record, you could be in a defensible position.

 

[belmontro]

I am not in the medical device field but I did work in the pharma industry for several years. We pretty much play by the same rules. Think of the Device History Record (DHR) as a record for your unique production runs. A record you could put in front of an FDA inspector in an audit and they would be able to figure out exactly what happened during the production run. The Device Master Record (DMR) is the template for the batch/lot specific DHR.

If I was the FDA and I was holding a physical copy of the DHR I would expect batch specific record that included physical documentation of the production procedure (in-process inspection records, cleaning records, line clearance documentation, BOMs, Labeling used for the run and the specific batch/lot numbers).

To get back to your question, I would include a page where physical copies of the labels are applied to the paper. This would be included in the DHR.

For example, I used to work in a packaging facility where we produced oral solid dose tablets (pills). Our batch records (DHR) included the bottle label (brand, qty, distributed by statement, tablet lot, packaging batch, ect.) a patient information leaflet, and a case label for the final shipper, these were pulled right off the production line. All of these documents (printed labeling) were captured in the DHR (batch record). I imaging you have a some sort of printed packaging. Throw that in the DHR. if the DHR does not include a space for it then you would need to create a space for it in the DMR or whoever owns that document would.

I hope that makes sense.

Ryan

 

[Mark Meer]

We had the same issue.

Our labels were templated, with a blank field for a serial number.
The serial number is printed in the field during production, and a time-stamped spreadsheet of all serial numbers printed is maintained.

During an FDA inspection, when asked for the primary identification label, we showed them the template, and the spreadsheet.

This was not sufficient.

We were given two suggestions on how to remedy:
1. Take pictures of the label after it is applied to the device; or
2. Print an extra copy of each label.

Either way, the picture or the copy of the label has to be included in the DHR.

MM.

 

[Marcelo]

I think pictures would be the best solution, as extra copies would require other controls (how do you confirm that the original was put into the device, of example).

The idea os the requirement is just that, that you have a traceability of the label put into the device, to try and reduce recalls related to labels.

Here is the comment from the preamble:

187. One comment on Sec. 820.184 stated that labeling should not be
required in the DHR because it is already required in the DMR. Another
comment stated that some devices have 25 or more labels and that only
the primary identification labels are necessary in the DHR. One comment
stated the requirement should be amended because it explicitly requires
that dates and quantities for each batch be in the DHR, while only
implying through the general requirement that the DHR must also contain
the batch test data.
FDA agrees that it may not be necessary to include all labeling
used in the DHR. However, FDA continues to believe, as it explained in
the preamble to proposed regulation published in the Federal Register
on November 23, 1993 (58 FR 61952 at 61968), that increased control
over labeling is necessary due to the many labeling errors resulting in
recalls. Therefore, FDA has retained a requirement related to labeling
in the DHR, but revised it to make it less burdensome. The requirement
was amended to ``the primary identification label and labeling'' which
is consistent with that contained in the original CGMP regulation,
Sec. 820.185. FDA believes that the requirement that the DHR contain
the primary label and labeling used for each production unit, coupled
with the labeling controls in Sec. 820.120, should help to ensure that
proper labeling is used and, hopefully, decrease the number of recalls
due to improper labeling.

 

[ltcmff]

I think pictures would be the best solution, as extra copies would require other controls (how do you confirm that the original was put into the device, of example).

The idea os the requirement is just that, that you have a traceability of the label put into the device, to try and reduce recalls related to labels.

Here is the comment from the preamble:

yes, i agree with that taking picture of pasted lable would be the best approach.but i am confusion that what is the concept of primary identification lable ? for X-RAY machine ,there are 5 or more ciritical components on which pasted identificaiton lables by supplier ,do we have to paste all the identificaiton labels in the DHR as a system manufacturer?
additionally, what is the approach for referring to a location? and for labeling ,how to document in the DHR?

looking forward to your reply.