Stability Tests In Hot, Wet Climates - The Global Harmonization

By BINDER

Stability testing for pharmaceutical products has now been harmonized globally. All pharmaceutical products must undergo defined specific testing conditions in accordance to local climatic conditions.

With the ICH guideline Q1A (R2) for stability tests which was finalised in August 2003, and revised in 2005 (withdrawal of the chapter Q1F, which defines additional stress testing conditions in zones III and IV) new changes have taken place. With the withdrawal of chapter Q1F, the 10 member ASEAN countries have introduced their independent technical dossier related to the ICH guidelines and have adapted the testing conditions to suit their own climatic conditions. The enforcement of the ASEAN ICH guidelines into the ASEAN countries is currently in progress.