§ 820.120 Device labeling - "shall be documented in the DHR"

T

ThatSinc

Quite Involved in Discussions
Hi All,

Hoping I can get some clarity from the wider audience regarding the requirements under 820.120 on device labelling about things that must be "documented in the DHR";

(b) Labeling inspection.
The release, including the date and signature of the individual(s) performing the examination, shall be documented in the DHR.

(d) Labeling operations.
The label and labeling used for each production unit, lot, or batch shall be documented in the DHR.

The guidance provided by the FDA here, seems to give conflicting advice on what checks and balances are needed on receipt and then again on use, particularly when it comes to pre-printed labels that do not include control numbers.


The devices manufactured at the company I'm working with now include a significant number of pre-printed labels and a single in-house printed label that includes the control number, UDI, DOM, etc. All labels have technical drawings.

Each of the pre-printed labels are inspected and released at the time of goods inwards inspection, which includes reference to the label part number, revision, and order number, though a physical copy of the label is not currently attached to the inspection record.

Each label is stored in separate boxes labelled with the part number and description, Each sheet of labels includes the part number and revision of the label, each label sheet where there are multiple labels on a single sheet cannot be mixed up based on the size/shape of the label and where it is intended to be applied.
Currently the labels would be withdrawn from stock and used, no further check and sign-off on being issued from stock for use.
Is this acceptable?

The devices are built in accordance with technical drawings that reference the part number of the label to be used.
The DHR would show that a particular assembly or finished device was manufactured in accordance with the technical drawings but there would be no documented record of what batch of labels was used on a particular batch of sub-assembly or finished device (paper based system, no electronic stock management).

I'm concerned that this is not sufficient to comply with the requirement to document the release of any label within the DHR (as you couldn't say explicitly from which order the label used came with to reference back to the inspection and release document) or the requirement to document which label was used, as again - you couldn't explicitly state which order of labels was used, particularly times when stock is running low and another order was delivered and released for use.

i.e. if you wanted to look at the DHR for a particular device, you may have a situation where the label used could have been from either of two orders, though the review and approval of the label would be available from both. would this be acceptable?


The raw material stock for the in-house printed label is inspected at goods-receipt and released to stock, and the printed label is verified as correct by the production supervisor following printing.
A copy of this label is attached to the DHR by the supervisor and signed when they are issued. I'm confident that this meets the requirements - but would be grateful for any confirmation or challenges on that.


Thanks in advance,

TS.
 
S

Swimming In The Soup

Starting to get Involved
I have two comments on your situation.

1. Medical Device Labels are required to be protected as to not be misbranded or adulterated. If someone takes (steals) controlled labels and places them on non-conforming product then you as a company may be liable. A reconciliation log can help there to account for the label inventory and at least give you due diligence support in court.

2. We have a pharma batch style process. Our filling record form is issued with an image of the appropriate label and the operators will attach a sample of the actual label used next to it to evidence the proper label used. As far as I can tell, there is no verification in your process that the supervisors attached label is actually the label placed on the product. That is a gap.
 
T

ThatSinc

Quite Involved in Discussions
Swimming In The Soup said:
1. Medical Device Labels are required to be protected as to not be misbranded or adulterated. If someone takes (steals) controlled labels and places them on non-conforming product then you as a company may be liable. A reconciliation log can help there to account for the label inventory and at least give you due diligence support in court.
Click to expand...

True, though I've worked for a few device companies where the majority of fixed-text labels are free-issue once they've been verified as good at goods inwards, and the labels with device specific control information on are issued per run and verified as correct prior to issue.
The device release then captures a review of the labelling being correct.
In your example, having a reconciliation doesn't stop anyone from saying they destroyed a label because it was damaged or mis-applied, and using it on a non-conforming device - it's either fraud with a false record, or fraud with no record.

This is why I have this concern because, as with most people posting around on Quality forms, the "we've always done it like that" defence is like red rag to a bull, and my only defence for thinking it's acceptable to free-issue the labels is that I've been in companies that worked like that before.

I don't think securing all labelling and having a designated person issuing labels for each job is necessary, and would just result in significant amounts of labelling on work benches rather in the appropriate storage location.

Swimming In The Soup said:
2. We have a pharma batch style process. Our filling record form is issued with an image of the appropriate label and the operators will attach a sample of the actual label used next to it to evidence the proper label used. As far as I can tell, there is no verification in your process that the supervisors attached label is actually the label placed on the product. That is a gap.
Click to expand...

The device authorisation for release includes review of the applied labels against the batch record.
 
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