Performing the Stability Tests
Purpose
In this phase of the stability study, you perform the stability tests for the storage conditions on the scheduled dates.
Prerequisites
You have defined the start date for the stability study.
Process Flow
You use the deadline monitoring functions to create inspection lots for the impending test dates. You can have the system do this automatically by means of a planned job.
You make sure the shop papers (for example, sample-drawing instruction) are available. The shop papers can be printed out automatically for each inspection lot when each lot is created.
You remove the stability samples from the storage conditions as indicated on the sample-drawing instruction and deliver them to the laboratories for testing.
For each stability sample, you perform a stability test by:
Selecting the respective inspection lot for a stability test using the work list for results recording
Note
You can create a list of all current inspection lots to be processed for a predefined time period. When you select the inspection lots, you can narrow down the selection of inspection lots using the following selection criteria:
Inspection lot origin
16
Work center
Inspection lot short text
The inspection lot short text contains the key for the stability study, the storage condition, and the package short text which specifies the test interval that is currently pending. The inspection lot short text can be also be supplied with customer-specific information using Business Add-In
QST02_STABILOT_WA
.
Inspecting each stability sample for a storage condition and recording test results for the inspection characteristics
Completing each stability test by making the usage decision for the inspection lot.
You perform the stability tests for all remaining test dates in the same manner as described above, until you have performed all planned stability tests for the duration of the stability study.