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The planned and actual storage condition parameters must be monitored for each storage condition combination.For example, 30 deg C/60% RH requires the monitoring of both the 30 deg C refrigeration and 60% RH ambient moisture content.You are given guidance on the creation and management of a stability study, including the assignment of its material sources, editing stability study variants and time points, and defining its storage packages.This chapter covers the following topics: Stability studies are performed in life sciences, chemical, and food and beverage industries to determine the effects of environmental conditions on product quality.This approach provides an extensive profile of material stability at a variety of temperatures and relative humidities.The following is an example of this type of study: Oracle Process Manufacturing (OPM) Quality Management stability studies let you create both simple and robust stability studies.Environmental conditions can impact product shelf life, and the viability of product formulation.Stability studies provide the supporting data that companies use to establish product storage requirements and expiration dating.

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Each test interval plan represents a unique set of testing time points that list the junctures at which you plan to test samples in the stability study.Stability studies are performed at various stages of the product development process.Early stages of stability testing are typically performed on laboratory materials to determine if the material to be produced has any inherent sensitivities to storage or shipping environments.Set up document numbering using the Samples tab in the Process Quality Parameters window for the organization where you plan to perform the sampling.Set up document numbering using the Stability Studies tab in the Process Quality Parameters window for the stability study organization.

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