Definition Test Site vs. Test Facility - FDA definition

[AnaMariaVR2]

I need help on this one. Does anybody know the FDA definition for test site versus test facility?

thanks,
Ana

 

[DrM2u]

Re: Test site vs. test facility?

I need help on this one. Does anybody know the FDA definition for test site versus test facility?

thanks,
Ana

I am not aware of any FDA-sanctioned definitions for these two terms. Usually a 'test site' is a physical location identified by a valid address. A 'test facility' is the combination of location, equipment, methods, personnel & environment where certain tests are conducted. A 'test facility' can exist within a 'site' that does more than just testing (i.e. within a manufacturing plant or R&D center) or can be a stand-alone facility referred to as 'test site' (i.e. Nevada Test Site). Often times the two terms are interchanged when one is referring to test site.

Hope this helps and maybe someone else has better info.

 

[jkuil]

From the OECD GLP guideline

Test facility means the persons, premises and operational unit(s) that are necessary for conducting the non-clinical health and environmental safety study. For multi-site studies, those which are conducted at more than one site, the test facility comprises the site at which the Study Director is located and all individual test sites, which individually or collectively can be considered to be test facilities.
Test site means the location(s) at which a phase(s) of a study is conducted.

 

[DrM2u]

From the OECD GLP guideline

Sounds like a good definition to me.

I am not sure if FDA subscribes to these guidelines as sanctioned interpretations. Is there any information regarding the relationship between FDA and OECD and/or how the guidelines are embraced by FDA? I'd hate to stir the OP down the wrong road by not making clear what is required and what is not relative to the question posted.

 

[Ajit Basrur]

I need help on this one. Does anybody know the FDA definition for test site versus test facility?

thanks,
Ana

FDA uses the definition "Test Facility" while OECD uses "Test Facility" and "Test Site". Refer the defintions used by FDA, EPA and OECD

According to FDA, the test facility means (according to 58.3) -

(g) Testing facility means a person who actually conducts a nonclinical laboratory study, i.e., actually uses the test article in a test system. Testing facility includes any establishment required to register under section 510 of the act that conducts nonclinical laboratory studies and any consulting laboratory described in section 704 of the act that conducts such studies. Testing facility encompasses only those operational units that are being or have been used to conduct nonclinical laboratory studies