Comply with GMP 21 CFR (820) / excisting ISO 9001 and ISO 13485

Hello everybody,

we are a German OEM for medical devices. One of our customer will have the US as a new target market.
So we need to comply with GMP 21 CFR part 820. We are already ISO 9001 and ISO 13485 certified.

How can we adjust 21 CFR part 820 to our existing QM-System? Right now I read through section by section of 21 CFR 820 to find out what is still missing to complete our processes. But it seems that 80% of our QM-System already comply with 21 CFR 820. I don't know if this is the right approach.

Appreciate any help.

Regards

 

Yes, it is the right approach. Manufacturers who comply with ISO 13485 are normally at least 80% in compliance with 21 CFR 820.

Cheers,
Ronen.

 

Thanks for the quick answer, Ronen!

Furthermore, I was wondering, since GMP is a law and ISO 9001/13485 is a "benefical" certification, where is the main focus during a GMP audit? What I mean is, ISO 9001/13485 prove the effectiveness of the QM-System and GMP prevents failed products before entering the market.
So I can't imagine that during a GMP audit the main focus would be e.g. prototypes.
Does someone has any experiences?

Regards

 

Daliane,

This should help you. http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074883.htm

Regards.

 

This one helps a lot! Thanks!