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July 1999

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Subject:
From:
Winfried RAPATZ <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Fri, 16 Jul 1999 08:14:02 +0200
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Scientific reason?

How to get science into very difficult to prove topics like that when we
get warning letters by some alien investigators for not following U.S.P.
methods in a very grave dangerous case like calculating the same
titration originally as Mg+ and not as Mg oxide as U.S.P. calls for?
U.S.P. is a nice thing, but where did the "c" go from cGMP. Like all
regulated things (and as much as it hurts my European feelings - it is
much more true for the EP) rather than changing them there is a big trend
in keeping them like they are, as long as we find a way to live with them.
Balanced requirements: I need about half a glass of water to swallow a
tablet which I have first touched with my fingers - my fist guess is, the
contribution in microbiological load by handling is orders of magnitude
higher than the one coming from the dosage form.
I would like to see a plate count of my fingers after eating spare ribs -
and believe it or not I am still alive.
True there are immune suppressed patients, but as clinical data shows
even there the entry path for infections is usually not via GI.
Have a nice Weekend
Winfried Rapatz
[log in to unmask]

By the way, I will be leaving my company end of September to work in
our pharmacy - so if you need someone based in Europe for audits or
consulting work - I am open for suggestions.

Mag. Winfried Rapatz
Waidhofnerstr. 43
A-3332 Rosenau
Austria
Tel: +43 (676) 32 99 423
Fax: +43 (7448) 2525 - 4


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