Hi All:

I am Jane from China, the fresh man of this forum. Glad to meet all of you! My company will set up the system of ISO13485. but I am not familiar with it.
Who can help me to answer below question?
1. The difference between GMP, FDA, and ISO13485
:)
Your help is appreciated!

I am Jane from China, the fresh man of this forum. Glad to meet all of you!

Welcome to the forums!

My company will set up the system of ISO13485. but I am not familiar with it.
Who can help me to answer below question?
1. The difference between GMP, FDA, and ISO13485


Other people may be able to give more detailed answers than I can, but here is some quick information:

FDA is the United States government Food and Drug Administration. It is the agency that regulates quality and safety of food, cosmetics, drugs and medical equipment in the USA.
GMP is the current Good Manufacturing Practices (http://www.fda.gov/cder/dmpq/) regulation of the FDA. The usual abbreviation is cGMP. As a governemnt regulation, it is part of the Code of Federal Regulations (CFR), Title 21, parts 210 and 211. That is usually written as 21CFR210-211.
ISO 13485:2003 Medical Devices - Quality Management Systems - requirements for regulatory purposes (http://www.iso.org/iso/en/CatalogueDetailPage.CatalogueDetail?CSNUMBER=36786&scopelist=) is the international standard that applies the requirements of ISO 9001:2000 to the manufacture of medical devices, with consideration to various government regulations. You can purchase a copy from ISO (http://www.iso.org/iso/en/CatalogueDetailPage.CatalogueDetail?CSNUMBER=36786&scopelist=) or your national standards orgainzation.Again, welcome to the forums!

Many thanks to your answer. I want to learn some quality knowledge. hope you can help me to sove some problem!:o

Jane, I think you will find what you are looking for in this file: Comparison of ISO 9001, ISO 13485 and the FDA QSR (http://elsmar.com/Forums/attachment.php?attachmentid=3831&d=1122065612). You may want to look at this thread: Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets (http://elsmar.com/Forums/showthread.php?t=6160) that is a discussion of the differences.

Hello all
New at the site. :)

How great to find this comparison!! :cool:
I was wondering if anyone can tell me how much the QSR has been updated since 2003?
The comparison was made in 2003, and I can see my last QSR 21 CFR - part 820 is updated may 2005.
Henrik :D

Hello all
New at the site. :)

How great to find this comparison!! :cool:
I was wondering if anyone can tell me how much the QSR has been updated since 2003?
The comparison was made in 2003, and I can see my last QSR 21 CFR - part 820 is updated may 2005.
Henrik :DWelcome to the cove Henrik. There were no significant changes to the QSR.

Thank you Al!
Have a good day!
Henrik:D

Hi al in drug dev reg

Welcome to the Cove :bigwave:

I deleted this post of yours as you started a new thread in the FDA scetion. Pls do not post multiple posts as the responses will not be well directed and you may not get the information that you would have expected.