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WHO Stability Guideline

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 ... [Pg.12]

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. [Pg.44]

The Development of the WHO Stability Guidelines (Contributed by Sabine Kopp)... [Pg.51]

In order to support the development of the regional WHO stability guideline for the EMR, the following countries have been selected for detailed evaluation ... [Pg.70]

The selection of the registration batches for stability testing is governed by more stringent requirements, as stipulated by ICH and WHO. These guidelines include the following criteria ... [Pg.469]

The WHO has established several separate parent guidelines on stability testing that covers the countries around the world. The WHO guidelines are aligned with the ICH stability guidelines for countries that fall within the climatic zones I and II. The WHO guidelines establish guidelines for the zones III, IVa, and... [Pg.490]

Stability testing Results of stability, physical as well as chemical tests, methodology used (WHO guidelines or ICH guidelines), validation ... [Pg.308]

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