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. 没有一个验证是必须的，这是因为，从字面的解释来看，只有生产过程多于一个批次并且是受到自然影响的工艺时才需要进行验证。化学家或许知道哪些参数是重要参数，却无法让反应进行充分以得到可接受的参数范围。查看更多
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