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.
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.
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.
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.