Hi quality folks,
I tried to dig in the fda.gov site to look for 21CFR820 latest chaneg history.
Changes occured in April 2007 apparently.
However, I did not find out any version history or any kind of change log.
Does anyone know where I can find this information ?
More, is there any reliable way of monitoring change at the fda.gov site?

Thanks for sharing:agree:

Bernie

Hi

I dont think you can find the changes on the FDA site. However, if you examine an up to date copy of 21CFR820, under each section there is a statement such as:

[61 FR 52654, Oct. 7, 1996, as amended at 65 FR 17136, Mar. 31, 2000; 65 FR 66636, Nov. 7, 2000; 69 FR 29829, May 25, 2005; 72 FR 17399, Apr. 9, 2007]

From here, you need to look at the actual page on the Federal Register. In this case, 2007 Volume 72 page 17399. This has the new text of 820.1(e), a change in the scope to reflect a change in the name of the Division of Small Manufacturers.

It's long winded, but it works!

I'm sure someone will have collated all the changes together, but I can't find a copy published on the internet.

Hi quality folks,
I tried to dig in the fda.gov site to look for 21CFR820 latest chaneg history.
Changes occured in April 2007 apparently.
However, I did not find out any version history or any kind of change log.
Does anyone know where I can find this information ?
More, is there any reliable way of monitoring change at the fda.gov site?

Thanks for sharing:agree:

Bernie

The change was only in the scope and reads -

§ 820.1 Scope.

(a) Applicability. (1) * * *
Manufacturers of blood and blood components used for transfusion or for
further manufacturing are not subject to this part, but are subject to subchapter F of this chapter.

These changes can be seen in the FEDERAL REGISTER Vol. 72, No. 216 (http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-21565.pdf) (Refer last page for 21 CFR Part 820)

Hi,
Thanks for the quick reply, great information !:thanx:

Well, we cannot say it is "lean" process provided by our FDA friends.
Just for fun, try to do the same doc control process in your company and show it to FDA inspectors. I bet you will received some 483's!
"Do what I say but don't do what I do...":cool:

Thanks again and have a nice day

Bernie


Hi

I dont think you can find the changes on the FDA site. However, if you examine an up to date copy of 21CFR820, under each section there is a statement such as:

[61 FR 52654, Oct. 7, 1996, as amended at 65 FR 17136, Mar. 31, 2000; 65 FR 66636, Nov. 7, 2000; 69 FR 29829, May 25, 2005; 72 FR 17399, Apr. 9, 2007]

From here, you need to look at the actual page on the Federal Register. In this case, 2007 Volume 72 page 17399. This has the new text of 820.1(e), a change in the scope to reflect a change in the name of the Division of Small Manufacturers.

It's long winded, but it works!

I'm sure someone will have collated all the changes together, but I can't find a copy published on the internet.

Hi,
Thanks for the quick reply, great information !:thanx:

Well, we cannot say it is "lean" process provided by our FDA friends.
Just for fun, try to do the same doc control process in your company and show it to FDA inspectors. I bet you will received some 483's!
"Do what I say but don't do what I do...":cool:

Thanks again and have a nice day

Bernie

Remember that FDA is part of the Federal Govt and getting any changes approved is not the same as in our organizations.

If you understand the process of the updates, its not that complex.

Refer Code of Federal Register : About (http://a257.g.akamaitech.net/7/257/2422/13feb20061331/www.gpoaccess.gov/cfr/about.html) -

The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis.

Titles 1-16 are updated as of January 1st
Titles 17-27 are updated as of April 1st Titles 28-41 are updated as of July 1st
Titles 42-50 are updated as of October 1st

Therefore 21 CFR will be updated once each calendar on Apr 1st.