Hi,
We are a contract manufacturer for medical device companies.
I am new at the Quality team and I see that the practice here is to report raw material (for the making of a component) lot numbers on the COC.
I have two questions, if you may:
1. Is it necessary to list ALL materials used with traceability (including glue lot number) or only the main/high risk?
2. Is it necessary to have one-one lot ratio. So, if we need two lots of raw-material-x, we would need to breakdown a finished lot to not create a situation, where two raw materials are "mixed" in our finished component lot (even though we would have traceability to both).
3. If we don't have a customer's explicit requirements for one-one raw-lots usage, is there any FDA requirement to do it?
(we are not FDA registered, only ISO-13485.)
:ca:
Thanks in advance,
Sue
We are a contract manufacturer for medical device companies.
I am new at the Quality team and I see that the practice here is to report raw material (for the making of a component) lot numbers on the COC.
I have two questions, if you may:
1. Is it necessary to list ALL materials used with traceability (including glue lot number) or only the main/high risk?
2. Is it necessary to have one-one lot ratio. So, if we need two lots of raw-material-x, we would need to breakdown a finished lot to not create a situation, where two raw materials are "mixed" in our finished component lot (even though we would have traceability to both).
3. If we don't have a customer's explicit requirements for one-one raw-lots usage, is there any FDA requirement to do it?
(we are not FDA registered, only ISO-13485.)
Thanks in advance,
Sue
- but customers don't dictate lot size for us, so it will be irrelevant).