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According to the DMF technical information check list promulgated by TFDA, the drug substance process validation data may be replaced by the process validation protocol and a representative batch record. Is it required for the representative batch record to be from one of the process validation batches?

刊登日期：2020-07-22  |  點閱次數 : 720 次 

The representative batch record is not necessary to be from one of the process validation batches.

 

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