Von der Risikoanalyse zum Risikomanagement-Prozess
Merck KGaA, Darmstadt
Risk analysis and risk management is used in the meantime in all areas of life. Whether consciously or unconsciously, risk analysis is an important tool for evaluation of different situations, projects and decision for this reason.
Even though risk analysis and risk management had been introduced in different industries, the pharmaceutical industry still has difficulties to use risk analysis beneficial and to convert the partly abstract matter and generic concepts – as they are described in the trilogy ICH Q8, Q9 and Q10 – in concrete systems for the company and to create living quality systems out of them.
Actually the sensible and collective use of risk analysis can provide a mid- or long-term benefit to facilitate better and more informed decisions and can provide regulators with greater assurance of a company’s ability to know their processes and deal with potential risks (ICH Guideline (International Conference on harmonisation of technical requirements for registration of pharmaceuticals for human use) Q9 Step 4, Quality Risk Management, valid from 9 November 2005).