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cGMP Defined



 

 

 

 

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

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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

 

Info Box

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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