9个回答
灌装机验证必须覆盖实际使用的全部速度范围(最低至最高),通过风险分析确定“最差条件”,并同步验证装量精度、密封性及无菌保障等关键指标。
也有相关483指出这一点
"The filling machine validation (study #VAL-2021-001) was performed only at the maximum speed of 200 vials/minute. However, routine production runs for Product X (Lot #12345, #12346) were consistently operated at 150 vials/minute. At this lower speed, fill weight variations exceeded ±10% (specification: ±5%), resulting in out-of-specification (OOS) results."
"No justification was provided for excluding the actual production speed (150 vials/minute) from validation. Process qualification batches failed to demonstrate control over fill volume accuracy across the intended operating range."
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