Bioequivalence and Bioavailability Forum

Dear ElMaestro,

❝ 1. How would you know it existed if I hadn't pasted the link ? Can you browse your way to it, assuming you know what you are looking for?

Yes, thanks to the BEBAC Guidance page
Scroll down to the very bottom of the EMA section, shortly above the HMA bullet point, and you'll get a link to the inspection procedures of the GCP IWG.

❝ 2. Is it a document that is "valid" / enforced? How would I know the answer to that?

Same as guidelines on the EMA web site : if it's still there, it's still valid.

❝ 3. It appears to be an annex. An annex to what and how do I find it?

The answer is in the title : it is an annex to the procedure for conducting GCP inspections. There are a total of 7 annexes, on specific topics.

❝ 4. Was "procedure" a verb in 2007? What does the title mean: "ANNEX III: TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA" (sorry about the caps but that's pasted from EMA's homepage).

I have it in lower case on the page of the GCP IWG, and with the colon in a different position ? Clearer that way.