ISO 9001 vs. cGMP - What are the differences?

[Lauren B. - 2009]

We are currently an ISO 9001 2000 company. Does anyone have any info on the differences in ISO 9001 vs cGMP?
Our parent company uses cGMP and I will need to know the differences in order to meet their requirements when printing for pharmecutical customers.

Is there not a cGMP standard like we use for ISO 9001? I have had trouble locating it, if there is.

[gaboring]

You may want to try this link to get some input for packaging and handling of drug products for FDA standards.

Good Luck!
Gaboring

www.fda.gov/cder/dmpq/cgmpregs.htm

[Linda W]

Lauren,

FDA has cGMP (current Good Manufacturing Practices) and they are published as Title 21 CFR Parts (several books each addressing the different parts from food to drug to medical devices, actual Part number depends on your industry. I'm in Medical device so they are 820, I believe pharmaceutical is 200-299 Drugs General and 300-400 Drugs Human) These are similar to ISO-9000:1994 requirements with some differences specific to the industry. Check the FDA website for more information.

Hope this helps!
Linda

[Vincnet]

Lauren,
the only thing I could add to Linda's brief and efficient reply is that if you are in the Medical Device field ISO 13485:2003 is supposed to be a standard compatible with FDA's cGMP (i.e. 21CFR part 820).

V