Challenges in Harmonizing Stability Testing Across Agencies
Pharmaceutical stability testing is governed by regulatory expectations from multiple global authorities, including USFDA, EMA, WHO, and CDSCO. While the ICH Q1A–Q1F guidelines aim to harmonize requirements, discrepancies still exist in how different agencies interpret, apply, and enforce stability testing protocols. This tutorial outlines the most common challenges companies face when attempting to align stability…
Read More “Challenges in Harmonizing Stability Testing Across Agencies” »