General Controls - GMP interpretation? General Requirements Concerning Records

Aphel

Involved In Discussions
#11
Re: General Controls - GMP interpretation? General Requirements Concering Records

Hello,

Thanks to all of you for your responses...but if it is ok for you...let us clarfy last details regarding that topic...hope this is ok for you.


The QSR states:

Sec. 820.180 General requirements. All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up. [...]


I have marked the first words in the first sentence in red and bold.
When you interpret these words..."this part" means occording to my understanding the part 820...so this sentence is talking about all records required in part 820...???

How do you interpret the first sentence in 21 CFR part 820.180...what does it mean to you, if you were only a class 1 medical device manufacturer??? What kinds of records do you need?

Thank you very much to all your guesses...

Best regards,
Aphel
 
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Ronen E

Problem Solver
Staff member
Moderator
#12
Re: General Controls - GMP interpretation? General Requirements Concering Records

Hello,

Thanks to all of you for your responses...but if it is ok for you...let us clarfy last details regarding that topic...hope this is ok for you.


The QSR states:

Sec. 820.180 General requirements. All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up. [...]


I have marked the first words in the first sentence in red and bold.
When you interpret these words..."this part" means occording to my understanding the part 820...so this sentence is talking about all records required in part 820...???

How do you interpret the first sentence in 21 CFR part 820.180...what does it mean to you, if you were only a class 1 medical device manufacturer??? What kinds of records do you need?

Thank you very much to all your guesses...

Best regards,
Aphel
It refers to the sections in part 820 that apply in your case. If you are exempt from some sections then obviously the FDA doesn't expect you to hold the documentation required by these sections.

Don't read too much into the regulation, and -

"Contrary to common belief, medical device regulations encompass a lot of common sense." (An old Chinese saying)

Cheers,
Ronen.
 
Last edited:
C

caroljean66

#13
Hi Aphel-
I agree with you regarding Section 820.180. I interpret general requirements to pertain to the following sections DMR, DHR and Quality Records as it says "required by this part". I thought the part they refer to is the 820.180 and related sections. Therefore, I figure that the company must have these. But then again, the device is GMP exempt so this doesn't make any sense.

If it is GMP exempt - what records do you need? Most required records have a connection to the GMPs if you have a quality system.

Is this how you see it? Did you find out an answer?
Thanks
cj
 
Last edited by a moderator:

Marcelo

Inactive Registered Visitor
#14
Hi Aphel-
I agree with you regarding Section 820.180. I interpret general requirements to pertain to the following sections DMR, DHR and Quality Records as it says "required by this part". I thought the part they refer to is the 820.180 and related sections. Therefore, I figure that the company must have these. But then again, the device is GMP exempt so this doesn't make any sense.
cj
The part is the whole 820.

If it is GMP exempt - what records do you need? Most required records have a connection to the GMPs if you have a quality system.
You may be exempt of having to show compliance with 21 CFR 820, however, it does not mean that it?s expected to work in chaos.

For example, if you do have a quality system in place even if there?s no requirement to show compliance, FDA expects that you maintain records of everything your quality system deems a record.

If you don?t, you still will need records in general, for example, manufacturing records and such, otherwise it would be impossible to work.
 
C

caroljean66

#15
Thank you Marcelo.

This was very helpful.
I have only worked with Class 2 devices and had to have every record required in 820 but now I work with Class 1 so I was a bit perplexed.

cj
 
Last edited by a moderator:

Ronen E

Problem Solver
Staff member
Moderator
#16
Hi Aphel-
I agree with you regarding Section 820.180. I interpret general requirements to pertain to the following sections DMR, DHR and Quality Records as it says "required by this part". I thought the part they refer to is the 820.180 and related sections. Therefore, I figure that the company must have these. But then again, the device is GMP exempt so this doesn't make any sense.

If it is GMP exempt - what records do you need? Most required records have a connection to the GMPs if you have a quality system.

Is this how you see it? Did you find out an answer?
Thanks
cj
Hi,

Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (820.198) or from general requirements concerning records (820.180).

Further, 820.180 is not "a part" in the regulations terminology. It is "a section". "Pasrts" don't have a dot in their designation, therefore in this context "this part" refers to 820 as a whole.

The records required by "this part", that GMP-exempt devices manufacturers must have, are (as a minimum) those stipulated under 820.198 & 820.180.

Cheers,
Ronen.

PS class I doesn't automatically mean GMP-exempt.
 
Last edited:
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