ICH Q10 (Pharmaceutical Quality System)

ICH Q10 is a guideline that defines a comprehensive framework for managing quality in pharmaceutical manufacturing. It emphasizes establishing a robust quality system to ensure medicines are consistently safe and effective. This includes procedures for process understanding, continuous improvement, risk management, and effective documentation. The goal is to build a proactive, flexible approach that can adapt to change while maintaining high standards, ultimately ensuring patient safety and product reliability throughout the product lifecycle.