The content focuses on the ICH guidelines related to the development, approval, and quality assurance of pharmaceuticals. It covers critical aspects such as stability testing, regulatory compliance, and the roles of various health agencies in ensuring drug safety and efficacy. Additionally, it addresses calibration and validation procedures for pharmaceutical equipment, impurity profiling, and the requirements for clinical trials and new drug applications. The overarching goal is to harmonize practices to meet international standards in drug development and registration.
ICH Guidelines (Q, S, E, and M) developed by the International Council for Harmonisation (ICH) to standardize pharmaceutical regulatory requirements globally.
