Guidance for Industry Q1E Evaluation of Stability Data – Free PDF download

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General Principles (2.1)

The design and execution of formal stability studies should follow the principles outlined in the parent guidance. The purpose of a stability study is to establish, based on testing a minimum of three batches of the drug substance or product, a retest period or shelf life and label storage instructions applicable to all future batches manufactured and packaged under similar circumstances. The degree of variability of individual batches affects the confidence that a future production batch will remain within  cceptance criteria throughout its retest period or shelf life.

Although normal manufacturing and analytical variations are to be expected, it is important that
the drug product be formulated with the intent to provide 100 percent of the labeled amount of
the drug substance at the time of batch release. If the assay values of the batches used to support
the registration application are higher than 100 percent of label claim at the time of batch release,
after taking into account manufacturing and analytical variations, the shelf life proposed in the
application can be overestimated. On the other hand, if the assay value of a batch is lower than
100 percent of label claim at the time of batch release, it might fall below the lower acceptance
criterion before the end of the proposed shelf life.


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