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。
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。
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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