QualityRiskManagementICHQ9Background.pptVIP

QualityRisk ManagementICH Q9Background Purpose of this part To provide information on the backgroundof the ICH Q9 document Give an aid by providing some points of discussions on the understanding of the quality risk management concept Agenda The ICH process ICH Q9 and other ICH guidelines From “Risk” to “Quality Risk Management” Opportunities, Challenges and Benefit Agenda The ICH process ICH Q9 and other ICH guidelines From “Risk” to “Quality Risk Management” Opportunities, Challenges and Benefit International Conference on Harmonisationof Technical Requirements for Registration of Pharmaceuticals for Human Use EWG’s include observers and constituted from both authorities industry Agenda The ICH process ICH Q9 and other ICH guidelines From “Risk” to “Quality Risk Management” Opportunities, Challenges and Benefit ICH Q-Documents Q1 Stability Q2 Analytical Validation Q3 Impurities Q4 Pharmacopoeias Q5 Quality of Biotechnological Products Q6 Specifications Q7 Good Manufacturing Practice Q8 Pharmaceutical Development Q9 Quality Risk Management Q10 Pharmaceutical Quality Systems ICH Q9 Link back to patient risk Risk Management across theProduct lifecycle for drug (medicinal) products Managing the risk of drug (medicinal) product use 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 How Q9 interacts with Q8 and Q10 ICH Q9 Link back to