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GMP Facility Design We
have a lot of experience in designing GMP facilities so they will be
easy to keep clean, have logical product and personnel flow, and
pass regulatory scrutiny. We can:
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review
your current design plans |
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help
you figure out a scientifically based remodel |
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help
you investigate problem areas |
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inform
you of the latest industry practices |
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determine
the best room classifications |
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integrate
your design so it meets both FDA and EU regulations |
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get
your facility operating smoothly, with fewer investigations
and corrective actions to slow down the day to day operations |
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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Set
environmental monitoring limits |
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Set up an effective,
reasonable environmental monitoring program, taking into
account FDA, USP, EU, and ISO considerations |
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Set
up a reasonable personnel monitoring program |
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Set up a data
trending system |
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