Storage Conditions

Storage Conditions

In general, a drug product should be evaluated under storage conditions (with appropriate
tolerances) that test its thermal stability and, if applicable, its sensitivity to moisture or
potential for solvent loss. The storage conditions and the lengths of studies chosen should be
sufficient to cover storage, shipment, and subsequent use.
Stability testing of the drug product after constitution or dilution, if applicable, should be
conducted to provide information for the labeling on the preparation, storage condition, and
in-use period of the constituted or diluted product. This testing should be performed on the
constituted or diluted product through the proposed in-use period on primary batches as part
of the formal stability studies at initial and final time points and, if full shelf life long term
data will not be available before submission, at 12 months or the last time point for which
data will be available. In general, this testing need not be repeated on commitment batches.
The long term testing should cover a minimum of 12 months’ duration on at least three
primary batches at the time of submission and should be continued for a period of time
sufficient to cover the proposed shelf life. Additional data accumulated during the assessment
period of the registration application should be submitted to the authorities if requested. Data
from the accelerated storage condition and, if appropriate, from the intermediate storage
condition can be used to evaluate the effect of short term excursions outside the label storage
conditions (such as might occur during shipping).
Long term, accelerated, and, where appropriate, intermediate storage conditions for drug
products are detailed in the sections below. The general case applies if the drug product is not
specifically covered by a subsequent section. Alternative storage conditions can be used, if
justified.