Process hazard analysis and critical control point identification

Excessive validation and process monitoring have not necessarily improved process reliability or product safety, and it is still difficult to know how to act responsibly when a control falls outside established limits. Process hazard analysis allows failures to be prioritized through risk-based triage so that pressures for both product safety and corporate profits are balanced fairly.

The current approach to product development and commercialization first identifies manufacturing processes that create or isolate a proposed product and then identifies test methods to provide evidence that those processes in fact produce acceptable product. Those processes are then validated to …