證檢查指南.jpg "美國FDA清洗驗(yàn)證檢查指南")
美國FDA清洗驗(yàn)證檢查指南
Ⅰ. 簡(jiǎn)介 對(duì)于清洗程序的驗(yàn)證的討論，已經(jīng)在FDA原料藥檢查指南和生物制品檢查指南中有了簡(jiǎn)要地解釋。這些官方文件明確表達(dá)了清洗驗(yàn)證的期望。 本指南通過討論一些可接受(或不可接受)的實(shí)例來建立檢查的連貫性…
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