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Facility Design/EM

 
 
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cGMP Defined

 

 

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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