Risk-Based Inspection Approaches in PIC/S

digi — Mon, 16 Jun 2025 08:15:44 +0000

Risk-Based Inspection Approaches in PIC/S Implementing Risk-Based Inspection Strategies Under PIC/S Framework The global pharmaceutical regulatory landscape has steadily evolved from fixed-schedule inspections to dynamic, risk-based approaches. Under the Pharmaceutical Inspection Co-operation Scheme (PIC/S), member authorities apply harmonized risk models to optimize inspection frequency, depth, and focus. These strategies are critical to resource efficiency, proactive...

PIC/S audit frequency – Pharma GMP

Risk-Based Inspection Approaches in PIC/S