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 : 1095 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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Drugs Medical Devices Consultation Services Health Technology Assessment International Cooperation

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)?

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