ICH Q9 Quality Risk ManagementICH Q9质量风险管理.pptVIP

PSH/SQQ II. 3 Quality risk management as part of… Development About development II.3: QRM as part of development To design a quality product and its manufacturing process to consistently deliver the intended performance of the product (see ICH Q8) To enhance knowledge of product performance over a wide range of material attributes (e.g. particle size distribution, moisture content, flow properties) processing options process parameters Quality by design: “Special Cause” or “Common Cause” Consequence: Frequent, major OOS Corrective actions eliminate “Special Cause” Result: Unstable proce