Production Unit Labeling - 21 CFR 820.184.e

[KenHealey]

Good morning,
At our company, we assemble units (footswitches), individually package them, then package XX units in a "master" or "shipper" package.
Our question pertains to labels/labeling of the "production unit." How does the guidance pertain to labels/labeling that will be discarded once the assembly is unpackaged.

Is the "production unit" labeling:

• labels on the unit after prior to packaging
• labels on the unit plus the single packaging labeling
• labels on the unit plus the single packaging labeling plus the multipack labeling

 

[Minda]

Are all of these labels the same? if they are carbon copies that are just applied to different locations then I am not sure how it would matter since there is no difference.

The FDA is interested in increasing control of labeling because many recalls are the result of labeling errors. Making it a requirement to keep the primary identification label and labeling used for each production unit in the DHR should assist with this control, and facilitate any necessary investigation.

 

[Ronen E]

Good morning,
At our company, we assemble units (footswitches), individually package them, then package XX units in a "master" or "shipper" package.
Our question pertains to labels/labeling of the "production unit." How does the guidance pertain to labels/labeling that will be discarded once the assembly is unpackaged.

Is the "production unit" labeling:

• labels on the unit after prior to packaging
• labels on the unit plus the single packaging labeling
• labels on the unit plus the single packaging labeling plus the multipack labeling

Hi,

In your case the production unit is a single footswitch so I would say that 21 CFR 820.184(e) refers in this case to ”labels on the unit plus the single packaging labeling”. However I would recommend keeping a copy / sample of the multipack labelling in the DHR as well.

Were you referring to a specific guidance? Which one?

Another thing to consider is by who the multipack is unpackaged, where, at what stage etc.

Cheers,
Ronen.

 

[KenHealey]

Hi Rolen,
Thank you for the post. The directive I was referring to is FDA 21cfr820.184.e. Apologies for leaving it out of the original post. Our labeling can be either lot or serial number production identifier, based on the labeler's requirements (we are a contract manufacturer for a component of a medical device). We will probably use all labeling, including the multipack labeling as well.

 

[KenHealey]

Hi Minda,
Thank you for the post. our plan will be to include all labels in the DHR.

 

[Ronen E]

Hi Rolen,
Thank you for the post. The directive I was referring to is FDA 21cfr820.184.e. Apologies for leaving it out of the original post. Our labeling can be either lot or serial number production identifier, based on the labeler's requirements (we are a contract manufacturer for a component of a medical device). We will probably use all labeling, including the multipack labeling as well.

Oh, I thought we were discussing a finished device...

As a component manufacturer part 820 doesn’t apply directly to you. Your clients may pose some documentation requirements (through PO, contract etc.) so that they comply with regulations that apply to them, but it is their responsibility to ensure regulatory compliance. Strictly speaking, the DHR is the finished device’s manufacturer cumulative production record, not your record. Again, they may ask you to provide some such records, or to have them available for inspection / investigation upon request, but from a regulatory perspective you have no such obligations (though you may well decide that you wish to do it for business reasons).

Cheers,
Ronen.