Planning the Stability Tests (SAP Library

Planning the Stability Tests

Purpose

In this process phase, you plan the stability tests, physically create the stability samples, place the stability samples into storage, and define a start date for the stability study.

Prerequisites

You have completed the following activities:

You have created the initial sample.

You have defined storage conditions in Customizing for Quality Management (Stability Study ® Basic Data ® Define Storage Conditions).

You have created a strategy that specifies the time intervals (packages) in which stability tests can be performed.

Process Flow

You specify storage conditions in the stability study.

When you select and assign a storage condition to the stability study, the system automatically creates a physical-sample record for the stability sample to be stored and tested under the storage condition.

You create a separate inspection plan for each storage condition specified in the stability study.

In the process of creating each inspection plan, you assign the strategy to the inspection plan header and the packages in the strategy to the appropriate inspection operations.

You create a testing schedule for the stability study.

Once you create and save the testing schedule, the system automatically creates an item in the testing schedule for each storage condition specified in the stability study.

You process the testing schedule to assign an inspection plan to each storage condition (item) in the schedule.

Note

If you do not assign an inspection plan to each storage condition in the testing schedule before you print the storage list (see step 6), the system will not be able to calculate and print the storage quantities for the stability samples.

You complete the testing schedule to set a status in the stability study that confirms that the scheduling activities have been completed.

You print the storage list for the stability samples.

The storage list specifies the sample quantity that will be needed for each stability sample and the storage conditions under which each sample is to be stored.

You physically create each stability sample in the specified quantity from the material remaining from initial sample.

You maintain the storage data for the stability samples.

You print the physical-sample labels, attach the labels to the respective stability samples, and place the samples into storage under the specified storage conditions.

Note

You can also print the physical-sample labels when you enter the storage data for each sample (in step 8).

You define the start date for the stability study.

Result

The planning activities for the stability tests have been completed and the stability samples have been placed in storage. On the basis of the start date you specified for the stability study, the system has calculated all testing dates for the entire duration of the study. You can view these dates using the functions for scheduling and deadline monitoring.