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FDA: Early Process Validation Studies Could Avert Preapproval Inspection Findings

 
• By Joanne S. Eglovitch

FDA officials stress the importance of nailing down the design of manufacturing processes early on to support later-stage process validation studies. Investigators find many of the deficiencies noted in preapproval inspections stem from inadequate Stage 1 process validation work. The best process validation programs are the ones that employ robust risk management models that explore how multiple variables can affect the manufacturing process.

FDA says that early-stage process validation studies must be robust enough to support commercial manufacturing. The agency is finding in preapproval inspections that manufacturers are not doing enough early stage design work to support later process validation studies, and it's issuing Form 483 inspectional observations as a result.

This issue was raised by speakers Sept. 13 at the Parenteral Drug Association/FDA Joint Regulatory Conference in Washington. They also...

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