Abstract 07 V1 I4

ICH Q9 Quality risk management guidelines from the ICH provide an excellent high level framework for the use of risk management in pharmaceutical product development and manufacturing. This guidance was developed within the Expert Working Group (Quality) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product across the product lifecycle."

(ICH Q9). Basic risk management facilitation methods (flowcharts, check sheets etc.) , Failure Mode Effects Analysis (FMEA) , Failure Mode Effects and Criticality Analysis (FMECA) ,Fault Tree Analysis (FTA),Hazard Analysis and Critical Control Points (HACCP) ,Hazard Operability Analysis (HAZOP) ,Preliminary Hazard Analysis (PHA) ,Risk ranking and filtering ,Supporting statistical tools these are well-recognized risk-management tools.

Keywords: QMR, risk assessment, methods of QRM, Potential applications.