Combining multiple lots of the same raw component for packaging or kitting

T

tnmedtech

#1
HI, I am a quality manager and am new to the manufacturing medical device industry....my career history has been in the clinical and pharma side of medical. Is there anyone out there who is combining multiple lots of the same raw material component into packaging and kitting whereby these lots are traceable through the package or kitting lot number? Do you have a reference that we could look to? And, is this conventional practice or what is your practice and experience?
Thank you in advance :)
 
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yodon

Staff member
Super Moderator
#3
Well, maybe this will at least get the ball rolling...

I guess my first question would be is traceability at that level required? For example, basic screws (e.g., to hold components together) probably don't need to be traceable whereas a high-risk component may need to be. So what is the risk of NOT having traceability?

I view traceability as essentially a risk mitigation for the company should a recall be required. High risk components that, if they fail, could lead to a recall need to be traceable to limit the recall to particular lot(s). If you mix those components, you may end up having to recall more than necessary.

Not aware of any standards or guidance on the matter.

This is a bit out of my comfort zone so if I'm too far out in the weeds, maybe someone can come back with better information.
 
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