英国工艺确认/验证战略:从概念到实际实施

Neil Beckman, Jerard Seghatchian
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引用次数: 4

摘要

在本通报中,在简要回顾了低纯度确认/验证工艺各阶段的当前要求后,我们提供了一些实际的例子,说明长期验证方案对工艺改进的有用性。希望从这一过程确认/验证中获得的经验能提高对可能影响过滤方案总体结果的关键变量的认识。
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UK strategy for process qualification/validation: from concept to practical implementation

In this communication, after a brief review of current requirements of various stages of leucodepletion qualification/validation processes, we provide some practical examples for the usefulness of long term validation programme for process improvement. It is hoped that the experience gained from this process qualification/validation enhances the awareness to key variables that can influence the overall outcome of filtration programme.

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