Definition of a “Significant Change” in Stability Testing
A “significant change” in stability testing refers to a substantial alteration in the quality, safety, or efficacy attributes of a pharmaceutical product during its shelf-life period. Such changes can indicate potential issues with the product’s stability and could impact its suitability for use.
The definition of a significant change may vary depending on regulatory guidelines and the specific attributes being assessed. Generally, a significant change is one that falls outside the established acceptance criteria or specification limits defined for stability testing. This can include factors like physical appearance, potency, impurities, degradation products, or any
It’s important to note that the criteria for what constitutes a significant change can be specific to the type of product, its intended use, and the regulatory requirements of the region in which it will be marketed.
