GMP: EMA and FDA – mutual recognition of inspections [GxP / QC / QA]
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 towards
- more inspections (more inspectees per year)
- more frequent inspections (more inspectinos per inspectee per year)
- more inspections taylored towards the type of corner-cutting that we have recently among producers and CROs recently (and note the present agreement doesn't cover anything beyond CMC).
- guidelines that force rather than suggest the industry to up the game in terms of vendor oversight.
if (3) 4
"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.
- GMP: EMA and FDA – mutual recognition of inspections - Helmut, 2017-03-03 11:42 [GxP / QC / QA]
- GMP: EMA and FDA – mutual recognition of inspections - nobody, 2017-03-03 16:15
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- GMP: EMA and FDA – mutual recognition of inspections - ElMaestro, 2017-11-10 19:10
- GMP: EMA and FDA – mutual recognition of inspections - DavidManteigas, 2017-11-14 15:47