21 CFR 820 vs 21CFR820 vs 21 CFR Part 820

[MissTSmith]

Hi,
I'm updating a Quality Manual and the associated SOPs.
I noticed inconsistencies, sometimes even within a document (i.e. 2 or 3 pages) where I see:

• 21 CFR 820
• 21CFR820
• 21 CFR Part 820
• 21CFR 820

So, is there a standard for this? The above is just an example...I'm finding when I go into Google I might get no results for "21CFR123" but do get results for "21 CFR 123"...but the next search of "21CFR555" gives me results but "21 CFR 555" gives me nothing...

Thanks.

 

[monoj mon]

I don't think this should be a matter of concern, unless you write the numbers wrong. Grab any random 510(k) summary and you will see that even FDA itself is not concerned about it. Just write it in your documents so that everyone can understand.

but the next search of "21CFR555" gives me results but "21 CFR 555" gives me nothing

By the way, I don't think there is any 21 CFR Part 555! It simply doesn't exists, that's why you aren't getting any search result. Check here
CFR - Code of Federal Regulations Title 21.

 

[Tagin]

The header on the FDA page for 820.20 is this:

[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2019]
[CITE: 21CFR820.20]

So, I think perhaps using the CITE format ("21CFR820.20") would be the way to go. So, to reference the 820 level would be "21CFR820".

 

[Ajit Basrur]

Hi,
I'm updating a Quality Manual and the associated SOPs.
I noticed inconsistencies, sometimes even within a document (i.e. 2 or 3 pages) where I see:

• 21 CFR 820
• 21CFR820
• 21 CFR Part 820
• 21CFR 820

So, is there a standard for this? The above is just an example...I'm finding when I go into Google I might get no results for "21CFR123" but do get results for "21 CFR 123"...but the next search of "21CFR555" gives me results but "21 CFR 555" gives me nothing...

Thanks.

Its like call a rose by any other name and it would smell as sweet

Tagin is correct but its not a concern the way you described your four bullets. To add some spice, here is the fifth one as a "section mark" symbol, 21 CFR § 820.60