folks who have a lot of
work to do," says
Joseph Coyne, RPh,
president of Coyne
Consulting in
Mundelein, Ill. "But
compliance with these
standards is a good
benchmark. It should
be price of entry for a
503A."
Ms. Hermanson sug-
gests a compounder
that makes it easy.
"Whenever there's a
new mandate, my
pharmacy reaches out
to let me know what it
is, and what steps
they're taking to com-
ply," she says.
How does the 483
look?
If, during a fed-
eral inspection, a prob-
lem is cited with the
design, monitoring or
control of a facility's
manufacturing
processes — as deter-
• 14,000 sq ft of cGMP compliant cleanroom space
dedicated to sterile preparations
• Industry-leading automation that reduces risk and
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• No preparation is released until all testing has been
completed
• Able to ship nationwide
• On-site audits are welcomed
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fagronsterile.com
Phone 316.7 73.0405
Fax 316.773.0406
Toll Free 877.405.8066
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Fagron is More…
