This chapter presents the global expectations of a stability program. It includes a thorough discussion of stability requirements of non-ICH regions as well as a discussion on how the climatic requirements are implied in the world. This comprehensive chapter gives an introduction of stability requirements for countries around the world. Discussions of World Health Organization (WHO) stability guidelines and Association of Southeast Asian Nations (ASEAN) stability requirements are also included.


Relative Humidity Climatic Zone Safety Margin Partial Vapour Pressure Southern African Development Community 
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© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.3R Pharma Consulting GmbHKelternGermany

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