Quality Risk Management Adoption More Wide Than Deep – Survey
This article was originally published in The Pink Sheet Daily
A high percentage of pharmaceutical companies say they have the quality risk management programs in their manufacturing facilities that US and EU inspectors are asking for. But many of them are not yet very mature.
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Inconsistency among pharmaceutical quality risk assessments drove regulatory authorities' surprise insistence on revising the ICH's 15-year-old Q9 guideline.
Despite the benefits in improving product quality and reducing product defects, the pharmaceutical industry is still struggling to incorporate ICH Q9 quality risk management principles into quality operations, and even more dispiriting, there is still lingering uncertainty on what constitutes quality risk management.
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.