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[PharmSciTech]RE: Segregation of hormone & steroid from the rest.

Hi Azman,

Just this month the University of Kentucky announced their new $17
million Center for Pharmaceutical Science & Technology facility. The new
CPST facility will be unique as it will be the first pharmaceutical
manufacturing facility to produce cytotoxic and non-cytotoxic drugs in
the same room at the same time. Check out the article at:

http://news.uky.edu/news/display_article.php?category=8&artid=1271

Also, you should be aware that there is a group working on an ISPE
guidance document called RISK-MAPP. It will be a guide to the
"Risk-Based Manufacture of Pharmaceutical Products". Basically this
document will give guidance on how to determine the controls necessary
for a compound based on its hazards, and how to handle the risks, rather
than lump compounds into classes such as "potent", "cytotoxic",
"steroid", etc. and simply impose controls (such as separate facilities)
based on the class with out any regard to the actual risk involved.

ISPE has just created a Community of Practice (CoP) for this effort
called the Containment COP. You can check this CoP out at:
http://www.ispe.org/page.ww?name=About+the+Containment+COP&section=Conta
inment+COP

As was already said, you should rely on your knowledge of the compounds
you manufacture, the hazards and risks involved with them, and then
implement the controls that are needed. Use your science.

I hope this helps,

Andy
andrew_w.walsh@roche.com

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