" ICH guideline" refers to a set of internationally recognized standards developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). These guidelines aim to harmonize the regulatory requirements for drug registration across major global markets like the US, EU, Japan. What is the ICH? The ICH is a unique organization that brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug development and registration. Purpose of ICH Guidelines: Ensure safety, quality, and efficacy of medicines. Reduce duplication of testing in different regions. Facilitate faster approval and access to new drugs across countries Main Categories of ICH Guidelines: ICH guidelines are grouped into four main categories, each identified by a letter: 1. Q – Quality Covers drug substance and product quality (e.g., stability, impurities, validation). Example: ICH Q1A – Stability T...