The long-standing industry norm of using three successful PPQ (Process Performance Qualification) batches for validation is no longer sufficient. Health authorities now expect companies to provide a robust justification for the number of batches chosen, shifting from a fixed rule to a risk-based approach.
A drug's manufacturing process is not static. Over a 10-20 year lifecycle, it will inevitably change due to raw material shifts or optimizations. Therefore, continued verification (PV Stage 3) is crucial for actively managing these expected deviations to maintain a state of control, not just for passive monitoring.
Success in a CMC role requires more than deep scientific expertise. It demands an equally strong understanding of regulatory guidelines and the ability to interpret and navigate them like a lawyer. Serving both patients and health authorities means mastering both disciplines is essential for program success.
The initial stage of process validation (PV Stage 1), which justifies all process limits and control strategies, is a significant but necessary resource commitment. Management often underestimates this phase, making it a difficult internal sell despite being a regulatory requirement for proving process control.