Dear Dennis,
Validation for what? Analytical or process? In general, EU member
states follow ICH guidance for validation. Presumably this is also
true of the USA - ?
Kind Regards,
Peter Lassoff, Pharm.D.
Associate Director
Worldwide Regulatory Affairs
PAREXEL International Ltd.
River Court, 50 Oxford Road
Denham, Uxbridge, Middlesex
UB9 4DL, UK
Tel: +44 1895 614427
Fax: +44 1895 614375
Mobile: +44 7740 899 222
<mailto:Peter.Lassoff@PAREXEL.com>mailto:Peter.Lassoff@PAREXEL.com
<http://www.PAREXEL.com/>http://www.PAREXEL.com/
-----Original Message-----
From: Dennis Melamed [<mailto:blt2go@erols.com>mailto:blt2go@erols.com]
Sent: 27 July 2001 20:01
To: RegAffairs
Subject: EU vs. FDA validation requirements
Michael,
We're trying to put together an article regarding the differences between
the EU validation requirements and those of FDA.
As you know, the new EU validation requirements went into effect in June.
Are there any meaningful differences?
Regards,
Dennis Melamed
Drug GMP Report
(202) 296-3069
PS: I have not forgotten my promise to send you issues. The publisher has
not yet given me access to our electronic archives. This should happen
shortly. The minute I get this access, I'll send you the newsletters.
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