Regional stability guidelines

It will have to be seen how these new conditions will be implemented in the WHO Member States. The intent is to make this information easily accessible to third parties on an international basis and to see the trend which of the two conditions is most commonly applied. 

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The Secretariat reminded the Committee that the WHO guidelines had been revised in the light of harmonization efforts in collaboration with ICH. Subsequently focus had been placed within regional harmonization initiatives on the recommendations for hot and humid conditions (referred to as Zone IV). After extensive discussion the Committee reached consensus that the WHO stability guidelines be amended to reflect conditions for Zone IV as follows ... 

Abstract 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. 

In order to support the development of the regional WHO stability guideline for the EMR, the following countries have been selected for detailed evaluation ... 

The principle that information on stability generated in any one of the three areas of the EC, Japan and the USA would be mutually acceptable in both of the other two areas has been established, provided it meets the appropriate requirements of this guideline and the labelling is in accord with national/regional requirements. 

An ICH Guideline on Stability Testing (QIA) was subsequently developed and published in 1993, after which it was adopted throughout the ICH region, namely the European Union, the USA, and Japan. Other countries followed the ICH guidelines in principle, for example Australia, Canada, Switzerland and so forth. In the following sections, some key aspects of the various documents are summarized. 

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