Module 3 2019

Why is Stability Data Required?

• The purpose of stability testing is to provide evidence on how the quality of a drug product varies with time under the influence of a variety of environmental factors

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Temperature

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Humidity

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Light…

• ………..and to establish a or a shelf life for the drug product and recommended storage conditions • Ultimately, a consistent/stable product quality and therapeutic benefit over the product shelf-life under various environment conditions

The Organisation for Professionals in Regulatory Affairs