"Annex III: To procedure for (...)": I am so confused :-) [Regulatives / Guidelines]

posted by Ohlbe – France, 2019-01-18 21:05 (1043 d 04:18 ago) – Posting: # 19785
Views: 2,331

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 :-D
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.


Complete thread:

 Admin contact
21,778 posts in 4,555 threads, 1,547 registered users;
online 12 (0 registered, 12 guests [including 3 identified bots]).
Forum time: Saturday 01:23 CET (Europe/Vienna)

Every new technology to me is like a newborn baby –
and you think that it’s become president
or it’s cure cancer or win a nobel prize.
But in the end, you’re perfectly happy
when it just stays out of jail […].    Eric Betzig

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz