Stability Study

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Stability Study

Purpose


Stability studies or shelf-life studies are conducted to track and examine how different environmental conditions (for example, temperature, brightness, moisture) affect a compound, a material, or a batch over a specified period of time.



For this purpose, you create physical samples of the material or batch and store them under controlled conditions for the duration of the study.



At specified intervals during the study, you remove these physical samples or parts of these samples from the various conditions and test them according to predefined inspection plans.



You can then use the results of these tests which have accumulated over the course of the study, for example, to check and confirm whether the desired or guaranteed life expectancy of the product conforms to the predefined recommendations for storage.


Implementation Considerations


You can conduct stability studies for many different types of self-produced or externally procured materials or products, regardless of your industry sector. In particular, the process industry routinely conducts stability studies in such sectors as pharmaceuticals, chemicals, cosmetics, and foods. Many of these industry sectors are closely regulated.



Various national and international regulatory agencies (for example, the Food & Drug Administration) and international guidelines (for example, the Good Manufacturing Practices) specify the scope and the types of products for which stability studies must be conducted (for example, as a prerequisite to being introduced on the market or as a means of testing the product on a regular basis during its market life).



Stability studies are also performed during the development processes of new products, for example, to determine the ideal composition of or packaging for a product, to ensure it will meet the minimum stability and shelf-life requirements for the intended storage conditions.


Integration


As a business process, the stability studyis a fully integrated in the SAP R/3 Enterprise release. The solution uses functions from the following areas:

• Quality Management (quality notifications, quality planning, and inspection lot processing)
• Asset Life-Cycle Management (maintenance planning and scheduling)
• Materials Management (material master, batch management, and bills of materials)

Features


The stability study allows you to define physical samples for storage conditions and to test and manage the physical samples for the entire duration of a study, beginning with the creation of a stability study and ending with the completion of the study.
The overall stability study process supports the following activities:

2. Creating the stability study
3. Creating, confirming, and testing the initial sample
4. Planning the stability tests
5. Performing the stability tests
6. Completing the stability study

Throughout these process phases, you will be able to:

• Flexibly control all process steps within a single, integrated environment
• Use the infrastructure of the stability study object (represented by a quality notification), which provides a variety of tools to perform all activities and process steps required in a stability study
• Enhance or modify the process steps to meet your company's specific requirements
• Easily trigger individual process steps using the action box in the quality notification
• Retain a transparent overview of the process (as recommended by GMP and FDA guidelines)
• Constantly track all process steps
• Design and print self-defined shop papers
• Use the SAP Workflow to support your activities

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