Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable)

Aphel

Involved In Discussions
#1
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
 
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shimonv

Trusted Information Resource
#2
When you read "All records required by this part", I take it to mean part 820.
In other words, you need to apply record controls to all QSR records.

Shimon
 

William55401

Involved In Discussions
#3
Aphel. You only need to apply record controls to the QSR sections that you must comply with. In this case, you are only responsible for the complaint handling element (and MDR since it is mentioned).
 

Tidge

Quite Involved in Discussions
#4
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?
When you read "All records required by this part", I take it to mean part 820.
In other words, you need to apply record controls to all QSR records.
@shimonv is correct. You may be exempt from section 820.30 Design Controls (consult the class I device table in that section). I am not aware of any other element of 21 CFR 820 which exempts manufacturer of class I devices.

You should also review the Preamble, including the response 160.
 

Aphel

Involved In Discussions
#5
Dear all,
Thank you for your response.

To be clear now:

As a medical device class 1 GMP exempt manufacturer - sections §820.198 and §820.180 apply (as part of "General controls")

So I Need not to establish required procedures (apart from §820.198) BUT I Need to establish required records... correct?

Example:
§820.50 requires a procedure for supplier Evaluation, and results of supplier Evaluation have to be recorded.

In my case - I Need not to establish the required procedure (because I am GMP exempt) , but I Need to document activities out of supplier Evaluation (due to the requirements of §820.180) - correct?

Thanks once again for your help to clarify my issue...
BR Aphel
 
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