Ich guidelines: The European Medicines Agency publishes

The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ( ICH ). Details of the ICH guidelines for pharmaceutical quality from Q1 to Q14 including stability analysis, evaluation of impurities, quality risk management and analytical procedure development. Navigating ICH Guidelines for Global Pharmaceutical Regulatory Compliance The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH ) plays a crucial role in standardizing drug development and regulatory practices globally. ICH guidelines are critical for ensuring that pharmaceutical products meet quality, safety, and efficacy standards across regions including the US, EU, Japan, Canada, and beyond. This article offers a deep dive into the ... The ICH website provides information on the quality guidelines for stability testing of new drug substances and products, including photostability testing. The guidelines are harmonised and implemented by various regulatory authorities around the world.