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If one of the three submission batches failed at accelerated condition,
is it necessary to initiating intermediate study?
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1.According to “USFDA Guidance for industry ANDAs: Stability Testing
of Drug Substances and Products - Questions and Answers”
If
accelerated data show a significant change or failure of any attribute in one
or more batches, an applicant should submit intermediate data for all three batches.
In addition, the submission should contain a failure analysis (i.e.,
discussion concerning the observed failure(s)).
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