Quality Risk Management Adoption Wider than it is Deep, Survey Shows
This article was originally published in The Gold Sheet
A high percentage of pharmaceutical companies say they have the quality risk management programs that US and EU inspectors are asking for. The trouble is that many of them are not yet very mature.
You may also be interested in...
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.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”
Questions about contamination control strategy raised as European Medicines Agency makes EU GMP Annex I revision a top priority in its 2021 work plan.