Inactive Registered Visitor
We are a medical device manufacturer and must therefore fulfill 21 CFR 820. For one of our customers, we are going to manufacture a new product which should be registered as a drug. We should therefore implement 21 CFR 211 as well.

Does anyone have a good comparison of the 2 regulations? A list of the additional requirements to fulfill the cGMP would be really useful...



Quite Involved in Discussions
Re: Differences between (c)GMP for drugs and devices

GMP CFR 820 - ISO 13485 comparison

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now, having said that, following additional aspects to be taken care interms of preparing for drug product submission.
1) am not really sure about the accreditation & FDA audit criteria...how do they recognize each other's audit-certifications etc., (considering that you might not be already audited by FDA)
2) if you can provide further details/outlines, probably there can be more clarity on certain documentation required for completing product registration.
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Inactive Registered Visitor
4 years later, I find myself in a similar predicament. If there are any resources cross-referencing drug GMPs to either ISO 13485 or FDA 21 CFR 820, I'd appreciate it!


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I've got two resources for you.

The first is the FDA guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations. You can easily identify medical device QSR elements (part 820) in part 211. It is here.

The second is the Pharmaceutical Supplier standard PS 9000. It helps pharma suppliers meet 211 requirements but is in a ISO 9001:2008/ISO 13485:2003 format. It is here.

Not correlations but almost.

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