Clinical Trials, Drug Manufacturers, Technology, Therapy Area

Stability Tests According to ICH Q1A (R2)

By Memmert

In 1990, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was born. This paper summarises the main contents of Guideline ICH Q1A (R2), which deals with the stability testing of new drug products and new drug substances.

The first part describes the general objectives of stability tests, the second part deals specifically with stability tests according to ICH Q1A (R2). Most of the stability samples are stored under standard climates. The third part of the paper therefore describes the most important requirements for a GMP-compliant climate chamber. In the last part, stability and climate tests from other industries are presented.

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