Release authorization before or after packaging per 21 CFR 820.80(d)?

[Mark Meer]

I'm in a bit of a dilemma, as to when to apply the final acceptance activities as per 21 CFR 820.80(d): before or after packaging the device?

The definition of "Finished device" clearly says "...whether or not it is packaged...", so this seems to indicate final acceptance can take place prior to packaging.

The other case for doing it before packaging, is that packaging is an "on-demand" activity, meaning that it doesn't take place until there is an order to fill. So a device can be "finished" long before it is actually packaged.

On the other hand however, packaging process and package labels are part of the DMR activities, so technically, as per 21 CFR 820.80(d)(1), completion of final acceptance records should take place after packaging activities are complete.

Any suggestions much appreciated...

 

[Mark Meer]

A related question: Can "date(s) of manufacture" (21 CFR 820.184(a)) be different from release authorization dates?

In otherwords, might it be possible to record the "date of manufacture" in the DHR as the date the finished (unpackaged) device was completed and tested (final acceptance activities), while the release authorization occurs after packaging?

Curious how others's systems are setup...

 

[somashekar]

I'm in a bit of a dilemma, as to when to apply the final acceptance activities as per 21 CFR 820.80(d): before or after packaging the device?

The definition of "Finished device" clearly says "...whether or not it is packaged...", so this seems to indicate final acceptance can take place prior to packaging.

The other case for doing it before packaging, is that packaging is an "on-demand" activity, meaning that it doesn't take place until there is an order to fill. So a device can be "finished" long before it is actually packaged.

On the other hand however, packaging process and package labels are part of the DMR activities, so technically, as per 21 CFR 820.80(d)(1), completion of final acceptance records should take place after packaging activities are complete.

Any suggestions much appreciated...

>> Finished device acceptance AND Release for distribution (let go / Courier picks up / Out of your gate) authorization are different.
>> The activities need not be just one, and are never as well.
>> Final acceptance activities are a combo of these.
>> 820.80(d)(3) uses the word individual(s).
>> Any date is that specific date of authorizing.
>> These can be sequentially different dates.

 

[Mark Meer]

Yes, it makes sense to have two separate processes:
1. assembly: which outputs finished (but unpackaged) devices
2. shipping: which includes packaging of device & release authorization.

My inquiry is specifically in the context of 21 CFR 820.80: which applies?

Just (1)? ...If so, 820.80(d)(1) would not be met because packaging is part of DMR activities.

Just (2), or Both? ...If so, does a production batch remain open until such time as all the devices actually ship?

 

[somashekar]

I can understand you.
DMR has to include the packaging and labeling at the primary level. Labeling is a regulatory need and DMR needs to cover this activity and release authorized to next level packaging more concerned with shipping requirements.
So...

1. assembly: which outputs finished (but unpackaged) devices

AND

Just (1)? ...If so, 820.80(d)(1) would not be met because packaging is part of DMR activities.

I am not comfortable

A production batch in your warehouse must have a DMR, since it is finished device released for distribution. (duly labelled and packaged)

The DMR authorization date and the shipping authorization date can be sequentially different. Both these can be linked within your traceability procedures for any necessary post market activities.