21CFR820.120 Device Labeling Requirements

M

MJW66

#1
I need some feedback. In 21CFR820.120(d),
(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.

My question is the following:

We are going the route of an electronic DHR. Can the label simply be referenced in the DHR in the form of listing the part number of the label drawing that was used for the group of devices manufactured or does an actual label need to exist (PDF or some other form) within the DHR? Another route would be to keep a physical sample and tie this to the electronic record (DHR). To be clear, the label drawing contains most of the information on the drawing, but obviously does not contain the control number for the group of devices manufactured. That would be entered at the time of production onto the label in the space indicated on the label drawing. So, if we referenced the label drawing only, it would not contain the control number, but that control number would be listed in the DHR.

So, can we simply reference the labeling drawing or does an actual artifact label with the control number used (lot) need to exist with the DHR? What constitutes "....documented in the DHR." Thanks for any help provided.
 
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M

MIREGMGR

#2
Re: 21CFR820.120 Device labeling

My employer understands the purpose of this rule to be to capture what was actually on the product batch that went out the door. So, we retain physical samples.

An electronic retain would not evidentiate the production process after arrival of the electronic file at the production station where the batch specific content is added and the labels are physically printed.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I would strongly argue for retention of a physical specimen, though I wouldn't rule out electronic substitutes, with the proper control measures in place. The further you get from the source evidence (i.e. actual physical label >>> PDF attachmant >>> label PN reference, etc.) the more rigorous you risk management and validation would have to be in that regard, to ensure that the discrepancy / deviation risk is acceptable.

As a general note, going forward with an electronic DHR you might be interested in part 11.

Cheers,
Ronen.
 
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