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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.
(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.