Lot Numbers of Plastic Disposables in an LDT (laboratory developed test)

M

Mandy

Involved In Discussions
We are a small startup R&D company in the process of developing a functional live-cell assay for cancer analysis. This will be an LDT (laboratory developed test) under CLIA approval, and we are also working on getting ISO 13485 approved as we hope to develop an IVD kit in the future.

Currently our staff all record the lot number of every reagent they use. My question is – do they also need to record the lot number of the plastic disposables they use, such as tubes, filters, well plates, etc.?

Thank you
Mandy
 
J0anne

J0anne

Joanne
Hello Mandy. Read your procedure for traceability requirements and check this against 7.5.3 of 13485.
 
M

Mandy

Involved In Discussions
Joanne, we don't have a traceability procedure yet. It's still in draft form until we finalize this issue (we're a small company building up our ISO 13485 QMS).
Any other advice?
Thanks
Mandy
 
J0anne

J0anne

Joanne
I have been in a similar situation and have recorded everything of significance used in the process. This way you will have a complete record that will be useful for analysis.
 
R

Rocke

Involved In Discussions
It may be sinpler to have logs of your plastic disposbles, assuming that you use them for other things as well.
We use logs for e.g. plates, so that we know during what period we used which lot. that way the technician doesn ot need to record the information EVERTY TIME they run an assay, which they really appreciate.
 
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