Masterarbeit

Stability Testing in the four climatic zones - Purpose, History, and Requirements

Dr. Monika Unha Baik (2011)

Stability testing studies shall exhibit in what way the quality of drug substance or drug product changes within time under the influence of various environmental conditions.

This work discusses the impact of temperature and humidity on drug stability in regard of chemical, physical, and microbiological stability, and sets it in relation to the four climate zones according to the regulatory requirements of stability storage conditions implemented in the current guidelines of the ICH regarding stability of drug products and drug substances.

The development of the Schumacher/Grimm system is presented, which is the basis for the current regulatory requirements of stability storage conditions.
Also, the evolution of the Köppen/Geiger climate zones system is presented, which is the most commonly climate system used by meteorologists.
The Köppen/Geiger system classifies the earth's climates based on native vegetation types in combination of latitude, temperature and precipitation, resulting in 30 sub-categories of climate zones.

Whereas the Schumacher/Grimm classification was developed to harmonize storage conditions for stability testing studies, resulting in four climate zones.
An analysis of randomly chosen locations all over the prove that these systems match each other leading to the conclusion that the current regulatory requirements are adequate to realistic enviromental conditions.

The global warming leading to a climate shift will result in more hot days, tropical nights, and heat waves in Europe. This will lead to a re-classification of the climate zones of the Köppen/Geiger classification system within 90 years.
Whereas climate zones III and IV (Schumacher/Grimm system) already take hot temperatures in account, regulatory bodies of countries in climate zones II might reassess their requirements for long-term storage conditions in the future.

 
Pages: 36 (incl. Annex: pages: 7)