Comparison of OEDC and US FDA GLP (Good Laboratory Practices)

[pseudoazurin]

Hi Everyone,

Good to see that Elsmar is back.

Got a few quick questions about Medical device GLP.

Does anyone have a comparison of OECD and US FDA GLP?

I have seen some discussion comparing ISO 17025 and GLP, but I would appreciate some authoritative answer on whether 1. improvement, 2. preventive action, 3, internal audits, 4. management review, 5. uncertainty, are not absolutely necessary.

Does anyone got a GLP template or essential list of SOPs?

Many thanks.

 

[HarrisSmith]

OECD is a unique forum where the governments of 34 democracies with market economies work with each other, as well as with more than 70 non-member economies to promote economic growth, prosperity, and sustainable development.

Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments

GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies

 

[pseudoazurin]

Hi there,

Thanks anyway!

I'm the original poster, and is looking for a comparison of OECD's GLP and US FDA's GLP system. I wonder whether anyone out there got experience on GLP.

 

[Marc]

A quick "Bump". Anyone here who can help? Thanks in advance.

 

[Ronen E]

No offence anyone, but I guess that's the way it is with freebies - sometimes you get lucky and sometimes you don't... The more unique the request, the lower the chances of success.

I never heard of "OECD's GLP" before reading this thread.

Sorry.