Sec. 820.120 Device Labeling & DHR - Count and Document All Labels

[Rene Tor]

Hi everyone.

My question belongs to the necessary documentation for the DHR for a Class III medical device.
According to sec. 820.120 device labeling it is required by the QSR to control labeling and packaging operations to prevent labeling mixups.
This in mind, is it really necessary to count and document the printed, reprinted, scrapped and glued labels?

Thx for every helpful answer.
BR Rene

 

[Marc]

Any medical device folks who can help on this?

 

[Al Rosen]

Hi everyone.

My question belongs to the necessary documentation for the DHR for a Class III medical device.
According to sec. 820.120 device labeling it is required by the QSR to control labeling and packaging operations to prevent labeling mixups.
This in mind, is it really necessary to count and document the printed, reprinted, scrapped and glued labels?

Thx for every helpful answer.
BR Rene

That's what's expected.

Sec. 820.120 Device labeling.


Each manufacturer shall establish and maintain procedures to control
labeling activities.
(a) Label integrity. Labels shall be printed and applied so as to
remain legible and affixed during the customary conditions of
processing, storage, handling, distribution, and where appropriate use.
(b) Labeling inspection. Labeling shall not be released for storage
or use until a designated individual(s) has examined the labeling for
accuracy including, where applicable, the correct expiration date,
control number, storage instructions, handling instructions, and any
additional processing instructions. The release, including the date
and signature of the individual(s) performing the examination, shall be
documented in the DHR.
(c) Labeling storage. Each manufacturer shall store labeling in a
manner that provides proper identification and is designed to prevent
mixups.
(d) Labeling operations. Each manufacturer shall control labeling
and packaging operations to prevent labeling mixups. The label and
labeling used for each production unit, lot, or batch shall be
documented in the DHR.
(e) Control number. Where a control number is required by
Sec. 820.65, that control number shall be on or shall accompany the
device through distribution.

 

[Weiner Dog]

Re: Sec. 820.120 Device Labeling & DHR

The two major reasons why devices are recalled are 1) mislabelings and 2) design issues.

Therefore, what is more of a hassle:
a) A proper labeling operation to make sure mislabeled products do not go out of the door (especially if they are class III devices- higher risk!) or
b) the embarrassment of a recall (not only on the QSR side, but business side too)?

Even though the QSR does not note label reconciliation (as does the pharma cGMP), it is a good practice to do so (especially when there are minor differences between product labels in a product family such as label color or differing product sizes).

Remember, the QSR is not the max, but min. Additionally, there is someone far worse than the FDA or a notified body... the patient's attorney.

 

[Ajit Basrur]

Agree with geochaz.

I have extended my Pharma experience into devices by maintaining a "Label reconciliation Register" for all the device labels.

 

[Scott Catron]

Re: Sec. 820.120 Device Labeling & DHR

what is more of a hassle:
a) A proper labeling operation to make sure mislabeled products do not go out of the door (especially if they are class III devices- higher risk!) or
b) the embarrassment of a recall (not only on the QSR side, but business side too)?

c) Explaining to an FDA investigator why you're not reconciling labels?

 

[Weiner Dog]

Re: Sec. 820.120 Device Labeling & DHR

c) Explaining to an FDA investigator why you're not reconciling labels?

Where does it say in the QSR (or preamble) that you have to conduct a label reconciliation activity? It does not! It says that one has to have a system in place to prevent label mixups.

(Of course, unless the FDA investigator is a drug investigator and should not be inspecting a device company in the first place... This is one of my pet peeves with the Agency...)

 

[Ajit Basrur]

Re: Sec. 820.120 Device Labeling & DHR

Where does it say in the QSR (or preamble) that you have to conduct a label reconciliation activity? It does not! It says that one has to have a system in place to prevent label mixups.

(Of course, unless the FDA investigator is a drug investigator and should not be inspecting a device company in the first place... This is one of my pet peeves with the Agency...)

Without label reconciliation, I am wondering how successful one would be with the FDA investiagor when QSR mentions to have a "system to prevent label mixups"

 

[Weiner Dog]

Re: Sec. 820.120 Device Labeling & DHR

Without label reconciliation, I am wondering how successful one would be with the FDA investiagor when QSR mentions to have a "system to prevent label mixups"

My point actually is: REGULATIONS, LAWS, AND STANDARDS ARE THE MINIMUM. Quality is common sense. Basically, it depends upon various criteria, including the layout of the labeling/packaging area, how the labels are applied, and the label and product designs and sizes. Inspection is to include qualified people because automated readers may miss key information (such as differing control numbers).

For example:

If a firm manufactures one product without labels having control numbers to be printed on-site or if the label can only fit one type of device, then incoming product acceptance (i.e. labels/packaging) with purchasing controls in combination with qualified personnel making sure the labeling area is clear of prior product labels and that the labeling operation is properly conducted (i.e. the labels are placed properly on the devices, etc.). Reconciliation would be silly (i.e. resource/cost insufficient) and would be quality overkill.

However, if there are gang labels (i.e. all kinds of labels on a big sheet) or similar sized labels for different devices, then there is a greater risk of label mix-ups (especially if labels differ by color for differing devices in a device family); thus label reconciliation may also need to be performed (besides the incoming product acceptance, label area exam, etc.).

Also don't forget about 21 CFR 820.70(i) (automated processes) and 820.75(a) (process validation) + 21 CFR 11 if label information is printed on-site by machine.