这句话怎么翻? no validation is required because wording allows interpretation that validation is needed when more than “a single batch” is produced, and development activities are by nature changing processes. the chemist may have an idea of which parameters are critical, but will not have performed the reaction enough times to establish the acceptable ranges. 没有要求验证是因为做验证需要一个以上的单批产品，而且在研发活动中工艺本身也在变化发展。化学实验者可确定哪些是关键参数，但无需为建立可接受的参数范围而将反应进行足够长的时间。 [ ]查看更多
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