Conclusion

Risk management is a process underpinned by a set of principles, supported by a structure appropriate to the organization and its external environment. The effective implementation of risk management must be proportionate to the level of risk, coordinated with the company's other activities, comprehensive in scope, integrated into routine activities and dynamic yet sensitive to changing circumstances.

The pharmaceutical industry, subject to precise regulatory conditions guaranteeing the safety of medicines, must set up an efficient and precise quality management system to guarantee control of each of its activities.

ICH Q8, Q9 and Q10 represent the pharmaceutical industry's essential recommendations, based on a solid scientific foundation, risk management and quality management. ICH Q9 is the standard for risk management. This text has been...