Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-11-22 10:23 CET (UTC+1h)

GMP: EMA and FDA – mutual recognition of inspections [GxP / QC / QA]

posted by ElMaestro - Denmark, 2017-11-10 19:10  - Posting: # 17970
Views: 180

Hi all,

I am so worried because of all this.

They make it sound like unnecessary inspections are the big problem and that this agreement is the method to get rid of the problem. It sounds right, sensible use of resources, almost LEAN, tax payers money at work, blahblahblah.

But in fact I have never heard of unnecessary inspections, not even when FDA and EMA 'by chance' have been at the same place more or less simultaneously. Especially not when FDA and EMA 'by chance' have been at the same place more or less simultaneously, actually.

I am totally afraid this means less inspections overall, and that would absolutely be a step in the wrong direction. Fraud is on the rise and it is big business - as it is now, it makes good sense to cheat or cut corners because the chance of getting caught is small to state it bluntly. The financial gain is extremely high, unless you just happen to be unlucky enough to get caught.

You will see me happy and singing and dancing when I see inititative towardsA good weekend to all of you.

I could be wrong, but…

Best regards,

No, I still don't believe much in the usefulness of IVIVCs for OIPs when it comes to picking candidate formulations for the next trial. This is not the same as saying I don't believe in IVIVCs.

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
17,494 Posts in 3,746 Threads, 1,086 registered users;
34 users online (0 registered, 34 guests).

The whole purpose of education is
to turn mirrors into windows.    Sydney J. Harris

BEBAC Ing. Helmut Schütz