1 . 3 Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards and ICH Q7

Regional GMP requirements , the ICH Q7 Guideline , Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”, and ISO quality management system guidelines form the foundation for ICH Q10 . To meet the objectives described below .ICH Q10 provides a harmonised model for a pharmaceutical quality system throughout the lifecycle of a product and is intended to be used together with regional GMP requirements .Regulatory processes will be determined by region .