For ANDA registration, whether batch records from each packaging type should be provided, if there are different packaging types (e.g. Alu-Alu PTP blisters and HDPE bottles)?

刊登日期:2019-11-13  |  點閱次數 : 1255 次 

Yes. Principally, batch records within 2 years from the date of application should be provided for each packaging type. Otherwise, master batch record and the weighing sheet within 2 years should substitute for batch record.



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