Dear all,
Would Need your Support for interpratation 21 CFR 820 --- Section 820.180 (Records).
As a class 1 device manufacturer our devices are exempt from GMP - apart from §820.198 and §820.180. This is clear for me.
My question:
820.180 - 1st sentence - requires: "all records by this part shall be maintained at the manufacturing Establishment..."
What does "all records" mean exactly?
Does it mean ALL records required within GMP sections e.g. design Control, purchasing, production, CAPA,... have to be created and filed?
OR
Does it mean only those records of applicable sections - in my case 820.198 - have to be created and filed?
Thank you very much in advance!
Regards, Aphel
Would Need your Support for interpratation 21 CFR 820 --- Section 820.180 (Records).
As a class 1 device manufacturer our devices are exempt from GMP - apart from §820.198 and §820.180. This is clear for me.
My question:
820.180 - 1st sentence - requires: "all records by this part shall be maintained at the manufacturing Establishment..."
What does "all records" mean exactly?
Does it mean ALL records required within GMP sections e.g. design Control, purchasing, production, CAPA,... have to be created and filed?
OR
Does it mean only those records of applicable sections - in my case 820.198 - have to be created and filed?
Thank you very much in advance!
Regards, Aphel