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制药用水系统验证
制药用水系统验证
产品介绍

制药用水系统验证,是按照 GMP 要求,通过文件、试验、数据、评估全过程证明制药用水(纯化水 PW、注射用水 WFI、纯蒸汽 PS)系统从原水预处理、制水、储存、分配、循环到终端使用,持续稳定产出符合药典质量标准水质的一套合规活动,是药品生产关键公用工程验证,直接关联药品安全性、有效性。


The verification of the pharmaceutical water system is in accordance with GMP requirements. It involves a comprehensive process including documentation,experiments, data collection, and evaluation to prove that the pharmaceutical water (purified water PW, water for injection WFI, pure steam PS) system, from raw water pretreatment, water production, storage, distribution, circulation to final use, continuously and stably produces water of quality that meets the quality standards of the pharmacopoeia. It is a set of compliant activities for the verification of key utility engineering in pharmaceutical production, and is directly related to the safety and efficacy of the drugs.

制药用水系统验证
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