Batch Numbering for medical tape

ifserav

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#1
Hi to everibody

We cut a medical tape and every time we cut a new jumbo of tape we chamge our batch number, is it right or should we stablish a batch size?, are ther any regulatory basis?

We want to certificate under ISO 13485 and GMP.

Thanks in advance

Sergio ?vila
 
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#2
Hi to everibody

We cut a medical tape and every time we cut a new jumbo of tape we chamge our batch number, is it right or should we stablish a batch size?, are ther any regulatory basis?

We want to certificate under ISO 13485 and GMP.

Thanks in advance

Sergio ?vila
There is no one way ... you have to state (document) how a 'batch' is defined, how batch numbers are generated and applied to finished products. If you are able to demonstrate the Batch Traceability by using a jumbo, thats fine.
 
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