Q9 Executive Summary ICH风险管理总结.ppt

QualityRisk ManagementICH Q9Executive summary for competent authorities and industry The situation today The situation today for both regulators and industry Increasing external requirements Increasing efforts and costs Growing complexity and scope of risks Empowerment Flexibility is needed Master complexity and streamline decision making Proactive disclosure build trust and understanding Improve communication through sharing best practice and science based knowledge Convert data into knowledge New Regulatory Paradigm ICH Regulators: FDA: New paradigm with the 21st Century GMP initiative EMEA: Revised EU directives MHLW: Revised Japanese law (rPAL) EU Japan became involved at ICH GMP Workshop in July 2003: 5 year vision agreed: “Develop a harmonised pharmaceutical quality system applicable across the life cycle of the product emphasizing an integrated approach to quality risk management and science” Consequent ICH Expert Working Groups (EWG): ICH Q8, on Pharmaceutical Development, doc. approved 2005 ICH Q9, on Quality Risk Management, doc. approved 2005 ICH Q10, on Quality Systems, topic accepted 2005 The new paradigm Incremental steps The Desired State driven by ICH Q9 Manage risk to patient, based on science: Product, process and facility Robustness of Quality System Relevant controls to assess mitigate risk Level of oversight required commensurate with the level of risk to patient for: Marketing authorisation applications Post-approval change review GMP inspections The Desired State Barriers to continuous improvement reduced or removed Improved manufacturing efficiency Sustained or improved product quality Specifications based on parameters that truly impact product quality Common understanding and language on risk Both, industry and competent authorities focus on areas of greatest risk and understanding of residual risks Pharmaceutical industry and quality risk management Pharmaceuticals have lagged behind related industries in adopti