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cGMP Defined

 

GMP Equipment Qualification Consulting

Many companies assume that since Process Validation does not have to be completed until your product nears market production, the same is true for equipment qualification.  However, the FDA and other regulators expect critical equipment qualification and sterilization validation to be completed before beginning the manufacture of any drug intended for use in humans (i.e., by Phase I).  The following systems should be considered for early qualification:

 
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Validation of autoclave load cycles

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Validation of equipment steaming cycles

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Qualification of critical manufacturing equipment:
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Fermentors

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Purification skids

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API or final product mixing tanks 

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Filtration systems

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Qualification of critical support equipment:
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API or final product refrigerators or freezers

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Cell banking freezers

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Stabilty sample refigerators, freezers, and incubators

We have many experts in validation and qualification that can help with everything from defining a cost effective, risk based approach to writing Master Plans, protocols and final reports and executing the work.

  

 

FDA on when to Qualify
"As indicated cGMPs develop with the phases of studies... However, validation of...sterilization should be in place prior to initiating clinical studies."

Loris McVittie, CBER
PDA/FDA Joint Sept 2001

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