While conducting component release testing on(b)(4)active pharmaceutical ingredient (API) batch(b)(4), your firm obtaineda failing assay result of(b)(4)% (specification(b)(4)% to(b)(4)%). 在检测某批次中某API组分放行测试时,你公司得到了一个不合格的含量结...
The product labels utilized on the OOS batch (Label lot no. (b)(4)) were also utilized in 3 other commercially released batches (H705563, H800616 and H705562). The firm’s decision to analyze retention samples from these three impacted batches and rete...
你们未充分评估对你们生产操作所做的工艺和设备变更(例如,API投料顺序,不同的XX型号),未识别出其对产品质量的影响。你们实施这些变更之后生产了若干批次,并放行至美国市场。使用这些未经的变更生产的几个批次含量均匀度不合格(OOS)。 Your OOS results suggest that your process is not robust. You did not ...
Violations and deviations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations and deviations, for determining the causes, for preventing their recurrence, and for preventing other violations and deviations in all your facilities. If yo...
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