Conducting a Stability Study (Overview)

Purpose

A stability study is a business scenario that is typically performed in laboratory environments to determine the long-term effects of specific storage conditions on a substance or product. Stability studies are usually performed during the research and development or production phases of a product's life cycle. To conduct a stability study, you must create physical samples of the substance or product to be examined and you then inspect these samples in a series of tests.

Process Flow

The overall stability study process is made up of several subordinate process stages as shown in the graphic below. The process steps described below depict a typical process sequence. Since the stability study is a solution that can be flexibly adapted to meet the needs of different users, other process sequences that differ from the one described below are also possible.

Note Note

Many of the process steps in the stability study are performed using follow-up functions in the action box of the quality notification or stability study. In the process description below, all steps that are triggered by follow-up functions are marked with an asterisk ( * ).

All steps in the process are documented by user statuses . These user statuses may allow or prevent the execution of other process steps.

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  1. Initiating the Stability Study

You initiate the stability study by creating a quality notification (type QS or QR , depending on whether or not you are conducting a study with reference to a material). You then perform the following additional activities in any desired sequence:

  • You create a physical-sample record for the initial sample to be delivered to your laboratory. *

  • You assign a stability bill-of-material to the stability study (only if the study is being conducted with reference to a material). *

  • You confirm the receipt of the initial sample when it arrives in your laboratory. *

  1. Initial Testing

You test the initial sample. Depending on the results of this test, you decide whether or not to continue the stability study. During the initial test, you perform the following activities:

  1. You create an inspection lot for the initial sample. *

  2. You perform the initial test by inspecting the initial sample and recording your test results.

  3. You complete the initial test by making the usage decision for the inspection lot.

  1. Stability Planning

If you decide to continue the stability study based on the results of the initial test, you begin planning the extended series of stability tests.

Note Note

If necessary, you can begin the stability planning activities during the initial testing phase.

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In the stability planning phase, you perform the following activities:

  1. You specify the storage conditions under which the stability samples will be stored in this stability study. *

  2. You create a testing schedule to plan the scope and frequency of the stability tests. *

  3. You create separate inspection plans for each storage condition.

  4. You process the testing schedule to assign the inspection plans to the respective storage conditions. *

  5. You complete the testing schedule. *

  6. You print the storage list.

    The system automatically calculates the quantities needed for the stability samples and prints these quantities on the storage list.

  7. You maintain the storage data for the stability samples in the system. *

  8. You physically create the stability samples, print and affix the physical-sample labels, and place the samples in storage under the predefined storage conditions.

  9. You define a start date for the stability study.

    The system automatically calculates all test dates for the duration of the study. *

  1. Stability Testing

You perform the stability tests.

This process phase may last several weeks or months, or as much as several years. During this phase, you perform the following activities:

  1. You monitor the testing dates.

    If necessary, you can influence the test dates (for example, by creating additional test dates, skipping certain test dates, restarting the scheduling process, and so on).

  2. You schedule a background job that periodically creates the inspection lots on the scheduled testing dates.

    You can flexibly create a work list of inspection lots in advance by specifying a lead time before the test dates.

  3. You remove the stability samples from storage on the specified test dates and perform the stability tests. Following each test, you return each stability sample to storage.

  4. You analyze the stability study process by performing evaluations.

  1. Completing the Stability Study

Once all planned stability tests have been performed, you complete the stability study.

Note Note

You do not have to complete the stability study as you originally planned at the beginning of the study. If necessary, you can:

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  • Cancel the stability study for all storage conditions or for selected storage conditions at any time *

  • Deactivate the stability study for all storage conditions or for selected storage conditions, for an indefinite period of time (for example, if you want to resume testing at a later date) *