Drug Makers Struggle to Establish ICH Q9 Risk Management Programs

Shelves laden with forgotten risk assessments? As drug makers assess quality risks to comply with ICH Q9, they are finding it difficult to integrate their assessments with their quality systems, which is the key to acting on their findings. Such a quality risk management (QRM) program can require tracking systems that span the globe and encompass the whole lifecycle of drug products. Benefits can include better control, quicker approval of changes, clarity about residual risks. Genentech's approach to "operationalizing" risk assessment is described. Hospira warning letter resulted from failure to update risk assessment. Key elements of a QRM program are presented.