Module 3 Presentations

07/05/2024

Climatic zones / Introduction

Climatic zones allow to reduce the number of different test conditions during stability testing The basis of the climatic zones has been developed by Paul Schumacher (1972) und Wolfgang Grimm (1986) They defined 4 different long-term test conditions, which match with the climatic conditions on the markets:

The Organisation for Professionals in Regulatory Affairs

41

Climatic zones / Introduction

Based on Grimm’s proposal the testing conditions have been defined.

In 2005, the WHO proposed to split the Climatic Zone IV into two different zones: ● IVa: Hot and humid climate ● IVb: Hot and very humid climate

The Organisation for Professionals in Regulatory Affairs

42

Made with FlippingBook Digital Proposal Maker