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GMP
Utility Design Utilities
such as water, steam, and compressed air often
receive intense regulatory scrutiny during inspections. We can
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review
your current design plans |
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help
you investigate problem areas |
| evaluate
your sanitization/cleaning program |
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inform
you of the latest industry practices |
Once
your facility is up and running, we can help you validate and
monitor its effectiveness.
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Validation
Master Plan |
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Protocols
and Reports |
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establish
the best sampling plan and frequency, taking into
account FDA, USP, EU, and ISO considerations |
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establish
reasonable limits |
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set up a data
trending program |
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Info Box |
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Water
is the article most plentifully used in pharmaceutical
drug preparation. Therefore, its
proper production is of considerable
importance. ... It should be remembered that the
experience collectively resident at FDA is considerable
in the matter of pharmaceutical water
systems.
T.H. Meltzer, M.W.
Jornitz,
and R.F. Tetzlaff
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