Comparison of ISO 13485, FDA and JGMP

G

Gert Sorensen

#1
I thought that maybe some of you might need this in your jobs. And having spent time making it I thought that I might as well share it. So, here is my table comparing the requirements of 13485, 820 and JGMP. There is probably room for improvement, and if any of you improve it then please upload it again.

:bigwave:
 

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R

Raeligh

#2
Re: Comparison of 13485, FDA and JGMP

Hi,
Its a great post.I feel it is very interesting and more informative.I too heard that good Manufacturing Practice (GMP) is a set of regulations that defines standards for manufacturing control and quality control of pharmaceuticals and must be followed when manufacturing pharmaceuticals. It was implemented in Japan in 1979 and revised in 1996 to be included in the industry required authorization. We design equipment that is in compliance with the various GMP regulations.Thanks for sharing with us.
 

howste

Thaumaturge
Super Moderator
#3
Thanks for the comparison - I know this takes a lot of time to put together. It looks similar to the one put together by Ed Kimmelman, but includes the JGMP.

:topic:
By the way, did anyone else have any problem with the file being corrupt? I had to download it and "Open and Repair" in Word to get it to open...
 
M

mlabardi

#4
I also had a problem with the file being corrupt. I downloaded it and used the "Open and Repair" feature.
 

howste

Thaumaturge
Super Moderator
#8
The regulatory definition of medical device is not in 21 CFR 820. It is in the law -- The Food, Drug, and Cosmetics Act.
That's what's referenced in the matrix on page 11.

Do you have a source for definitions of "active implantable medical device" or "active medical device" other than ISO 13485?
 

Stijloor

Staff member
Super Moderator
#9
That's what's referenced in the matrix on page 11.

Do you have a source for definitions of "active implantable medical device" or "active medical device" other than ISO 13485?
How about this:

DEFINITIONS - ACTIVE MEDICAL DEVICES

"active medical device" means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.

(90/385/EEC - OJ. L. 189/17)
 
T

treesei

#10
Active device
The term "active" refers to any medical device that can only serve its intended use with the supply of power by any means including, but not limited to line, battery, or gas power. Examples of active devices include ventilators, pacemakers, and patient monitoring devices. (FDA. A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems).

Implant
Implant means a device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain therefor a period of 30 days or more. (This FDA definition can be found in various parts of 21 CFR. FDA may include some devices that stay in human body for less than 30 days).
 
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