General Controls - GMP interpretation? General Requirements Concerning Records

A

Aphel

Involved In Discussions
Hello,

I have a question regarding a the following FDA Statement:

"FDA has determined that certain types of medical devices are exempt from GMP requirements. These devices are exempted by FDA classification regulations published in the Federal Register and codified in 21 CFR 862 to 892. Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (21 CFR 820.198) or from general requirements concerning records (21 CFR 820.180)."

The last sentence contains ... "general requirements concering records (21 CFR 820.180)" ... now my question: What records are we talking about here?
Does the requirement mean, that there also has to be a Device Master Record and Device History record - or not?
I ask, because the requirement for DMR and DHR is defined in §820.181 respectivly §820.184 and not under §820.180.
Thats why I am little bit confused about the meaning of §820.180.

Can you explain this to me?

Thank you very much in advance for your help.

Best regards,
Aphel
 
sagai

sagai

Quite Involved in Discussions
Re: General Controls - GMP interpretation? General Requirements Concering Records

Hi Aphel!
Records are not only records are in the DHF, DMR, DHR but others are defined by 21CFR820.
For example, internal audit report, CAPA record, training record, etc.
The exact number of records relates to your question highly depends on how your QMS reflects to the requirements set forth by 21CFR820.
Regards
Szabolcs
 
A

Aphel

Involved In Discussions
Re: General Controls - GMP interpretation? General Requirements Concering Records

Hello sagai,

So in detail this means, that I do not need a dmr or a dhr for a gmp exempt class 1 medical device, right?

Best regards,
Aphel.
 
Ronen E

Ronen E

Problem Solver
Moderator
Re: General Controls - GMP interpretation? General Requirements Concering Records

Aphel said:
Hello,

I have a question regarding a the following FDA Statement:

"FDA has determined that certain types of medical devices are exempt from GMP requirements. These devices are exempted by FDA classification regulations published in the Federal Register and codified in 21 CFR 862 to 892. Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (21 CFR 820.198) or from general requirements concerning records (21 CFR 820.180)."

The last sentence contains ... "general requirements concering records (21 CFR 820.180)" ... now my question: What records are we talking about here?
Does the requirement mean, that there also has to be a Device Master Record and Device History record - or not?
I ask, because the requirement for DMR and DHR is defined in §820.181 respectivly §820.184 and not under §820.180.
Thats why I am little bit confused about the meaning of §820.180.

Can you explain this to me?

Thank you very much in advance for your help.

Best regards,
Aphel
Click to expand...

Can you please specify the exact quote's source?

Thanks,
Ronen.
 
A

Aphel

Involved In Discussions
Re: General Controls - GMP interpretation? General Requirements Concering Records

Hello everybody,

I still have no idea what records are meant in §820.180... in conjunction with GMP exempt class 1 medical devices...???

Is the GMP talking about every record out of §820 that is not part of the DMR and DHR?


Is there no one who can help... :-(

nice regards,
Aphel
 
Ronen E

Ronen E

Problem Solver
Moderator
Re: General Controls - GMP interpretation? General Requirements Concering Records

Aphel said:
Hello everybody,

I still have no idea what records are meant in §820.180... in conjunction with GMP exempt class 1 medical devices...???

Is the GMP talking about every record out of §820 that is not part of the DMR and DHR?


Is there no one who can help... :-(

nice regards,
Aphel
Click to expand...

Hello,

The phrase you quoted is (as far as I understand) non-binding guidance. Look for the actual regulation language to understand what the GMP exemption includes / excludes, or formally contact the FDA to get a binding and definite answer.

Cheers,
Ronen.
 
sagai

sagai

Quite Involved in Discussions
Re: General Controls - GMP interpretation? General Requirements Concering Records

I do not know.
I have note yet faced with this gmp exemption.
Regards
Szabolcs
 
D

Derrill Darby

Re: General Controls - GMP interpretation? General Requirements Concering Records

I just found this topic while i was on a search so i am late to the discussion. Did you ever get an answer, i am searching for the same?

Thanks!
 
T

treesei

Re: General Controls - GMP interpretation? General Requirements Concering Records

Here is how I interpret it: Even a company is exempted from cGMP, it still has a QMS and will still generate a lot of records (hard to believe it will not have inspection records, for example). Whenever there is a QMS related record, 820.180 applies. Does it need 820.181? Not formally. A normally operating manufacturer will still have at least part of the DMR content (product spec for example) but may not organize them or maintain them in a way 820.181 requires.

:2cents:Open to further discussion.:)
 
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