FDA Guidance Exempts Legacy Products from Early Stage Process Validation; Endorses Use of PAT
This article was originally published in The Gold Sheet
FDA’s final process validation guidance clarifies that legacy products, or products that are currently on the market, will be exempt from early stage process validation. The guidance also endorses the use of process analytical technology for monitoring product quality.
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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.
An upcoming ISPE discussion paper aims to help manufacturers decide on the correct number of batches to run to demonstrate that a process is in a state of control in early stage validation studies.
Pharmaceutical manufacturers need to carefully plot out how they are going to manage the validation activities with their manufacturing partners. Not planning out these activities before the knowledge transfer can raise the ire of FDA.