FDA: Early Process Validation Studies Could Avert Preapproval Inspection Findings
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.
Register for our free email digests: