Hi All,
Hoping I can get some clarity from the wider audience regarding the requirements under 820.120 on device labelling about things that must be "documented in the DHR";
(b) Labeling inspection.
The release, including the date and signature of the individual(s) performing the examination, shall be documented in the DHR.
(d) Labeling operations.
The label and labeling used for each production unit, lot, or batch shall be documented in the DHR.
The guidance provided by the FDA here, seems to give conflicting advice on what checks and balances are needed on receipt and then again on use, particularly when it comes to pre-printed labels that do not include control numbers.
The devices manufactured at the company I'm working with now include a significant number of pre-printed labels and a single in-house printed label that includes the control number, UDI, DOM, etc. All labels have technical drawings.
Each of the pre-printed labels are inspected and released at the time of goods inwards inspection, which includes reference to the label part number, revision, and order number, though a physical copy of the label is not currently attached to the inspection record.
Each label is stored in separate boxes labelled with the part number and description, Each sheet of labels includes the part number and revision of the label, each label sheet where there are multiple labels on a single sheet cannot be mixed up based on the size/shape of the label and where it is intended to be applied.
Currently the labels would be withdrawn from stock and used, no further check and sign-off on being issued from stock for use.
Is this acceptable?
The devices are built in accordance with technical drawings that reference the part number of the label to be used.
The DHR would show that a particular assembly or finished device was manufactured in accordance with the technical drawings but there would be no documented record of what batch of labels was used on a particular batch of sub-assembly or finished device (paper based system, no electronic stock management).
I'm concerned that this is not sufficient to comply with the requirement to document the release of any label within the DHR (as you couldn't say explicitly from which order the label used came with to reference back to the inspection and release document) or the requirement to document which label was used, as again - you couldn't explicitly state which order of labels was used, particularly times when stock is running low and another order was delivered and released for use.
i.e. if you wanted to look at the DHR for a particular device, you may have a situation where the label used could have been from either of two orders, though the review and approval of the label would be available from both. would this be acceptable?
The raw material stock for the in-house printed label is inspected at goods-receipt and released to stock, and the printed label is verified as correct by the production supervisor following printing.
A copy of this label is attached to the DHR by the supervisor and signed when they are issued. I'm confident that this meets the requirements - but would be grateful for any confirmation or challenges on that.
Thanks in advance,
TS.
Hoping I can get some clarity from the wider audience regarding the requirements under 820.120 on device labelling about things that must be "documented in the DHR";
(b) Labeling inspection.
The release, including the date and signature of the individual(s) performing the examination, shall be documented in the DHR.
(d) Labeling operations.
The label and labeling used for each production unit, lot, or batch shall be documented in the DHR.
The guidance provided by the FDA here, seems to give conflicting advice on what checks and balances are needed on receipt and then again on use, particularly when it comes to pre-printed labels that do not include control numbers.
The devices manufactured at the company I'm working with now include a significant number of pre-printed labels and a single in-house printed label that includes the control number, UDI, DOM, etc. All labels have technical drawings.
Each of the pre-printed labels are inspected and released at the time of goods inwards inspection, which includes reference to the label part number, revision, and order number, though a physical copy of the label is not currently attached to the inspection record.
Each label is stored in separate boxes labelled with the part number and description, Each sheet of labels includes the part number and revision of the label, each label sheet where there are multiple labels on a single sheet cannot be mixed up based on the size/shape of the label and where it is intended to be applied.
Currently the labels would be withdrawn from stock and used, no further check and sign-off on being issued from stock for use.
Is this acceptable?
The devices are built in accordance with technical drawings that reference the part number of the label to be used.
The DHR would show that a particular assembly or finished device was manufactured in accordance with the technical drawings but there would be no documented record of what batch of labels was used on a particular batch of sub-assembly or finished device (paper based system, no electronic stock management).
I'm concerned that this is not sufficient to comply with the requirement to document the release of any label within the DHR (as you couldn't say explicitly from which order the label used came with to reference back to the inspection and release document) or the requirement to document which label was used, as again - you couldn't explicitly state which order of labels was used, particularly times when stock is running low and another order was delivered and released for use.
i.e. if you wanted to look at the DHR for a particular device, you may have a situation where the label used could have been from either of two orders, though the review and approval of the label would be available from both. would this be acceptable?
The raw material stock for the in-house printed label is inspected at goods-receipt and released to stock, and the printed label is verified as correct by the production supervisor following printing.
A copy of this label is attached to the DHR by the supervisor and signed when they are issued. I'm confident that this meets the requirements - but would be grateful for any confirmation or challenges on that.
Thanks in advance,
TS.