Standardized Stability and Shelf Life Analysis is a required step in the manufacture of all drugs and foods, to determine the shelf life. In general, the concern is that products retain the same properties and characteristics that they possessed at the time of packaging.  These properties must be within specified limits throughout a period of storage and use.

Toxicological, Microbiological, Physical and Chemical Stability and Shelf Life Studies are conducted in a wide variety of industries from Pharmaceutical, Food and Beverage, to Industrial. Specific guidelines published by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) and also the U.S. Food and Drug Administration (FDA) provide details on analytic approaches and workflows that are acceptable for these analyses. However, in addition to the specific data analysis steps, it is critical that analyses are validated and properly documented, and embedded into a secure system that guards the integrity of all analytic reporting.

Statistica Stability is a validated solution which has been installed and successfully utilized at some of the largest manufacturing facilities in the world. This solution successfully integrates enterprise-wide role-based security, predefined data configurations and analysis configurations, customizable reporting and flexible analytical tools to handle any analysis requirement. All analyses follow ICH and U.S. FDA guidelines, meeting the stringent requirements established by these organizations.

Intrinsic factors influencing Shelf Life:

  • Initial Quality
  • Inherent Nature of the Product
  • Product Formulation

Extrinsic factors influencing Shelf Life:

  • Processing methods
  • Packaging
  • Transport and Storage Conditions

 

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