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ICH Q1A(R2)

Meaning

ICH Q1A(R2) is an internationally harmonized guidance document established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), specifically addressing stability testing of new drug substances and products. This guideline sets forth the comprehensive framework for designing and executing stability studies to demonstrate how the quality of a pharmaceutical active ingredient or finished product varies over time under the influence of environmental factors like temperature, humidity, and light. Adherence to ICH Q1A(R2) is mandatory for regulatory approval, ensuring that drug products maintain their identity, strength, quality, and purity throughout their designated shelf life.