GMP–Too much of a good thing!
Bob Pietrowski
My article in the last Journal on why EUGMP expectations are now the toughest in the world drew numerous emails from readers – most notably from readers in the US who felt that I was criticising the FDA and USGMP standards!
Let me be perfectly clear. I draw absolutely no pride from my belief that EUGMP requirements are tougher than those of FDA – far from it. I believe that Regulatorsa ll over the world, but particularly in parts of the EU, are in danger of pursuing higher levels of GMP for GMP’s sake, and not for the benefit of the patient. Recent initiatives through ICH represent a welcome attempt to bring everyone’s attention back to what is really important.
Just because GMP requirements are getting tougher, it doesn’t mean that they are getting better or that patients are being better protected.