Stability Testing Question & Answers –If one of the three submission batches failed at accelerated condition, is it necessary to initiate intermediate study

If one of the three submission batches failed at accelerated condition, is it necessary to initiating intermediate study?

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)).