Chinese Standard: GB/T 28671-2012

Guidelines for pharmaceutical machinery validation

全国制药装备标准化技术委员会(SAC/TC 356)

本标准规定了制药机械（设备）（以下简称制药设备）验证的术语和定义、验证目的、原则、程序和方案。
本标准适用于指导制药设备的设计确认、安装确认、运行确认和性能确认等验证工作。

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