Unplanned Activities in the Stability Study

Overview

Over the course of a stability study, you may need to perform certain activities or tasks that you cannot plan in advance, but which you perform "ad hoc", as the need arises. Examples of such activities may include the following scenarios:

  • You want to perform an unplanned stability test for a storage condition on a date that lies between the scheduled test dates.

  • You want to complete the stability study for a storage condition prematurely.

  • You want to include additional inspection characteristics or test dates for a storage condition after the stability study and the scheduling process has already been started, and after calls with inspection lots have already been created.

This section of the stability study documentation contains information that describes the following unplanned activities: