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July 1999


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Winfried RAPATZ <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Fri, 16 Jul 1999 08:14:02 +0200
text/plain (42 lines)
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
Tel: +43 (676) 32 99 423
Fax: +43 (7448) 2525 - 4

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