The submitted drug product samples should be from a batch made with the proposed market formulation.

所递交的制剂样品必须是根据拟定的上市配方生产的。

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For example, if a program is assigned to generate batch records then it should account for the maximum number of different lots of each component that might be used in the formulation.

例如，如果一个程序被指派能够产生批记录，那么就应该说明在配方中所用到的每个成分的不同批次的最大量。

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