Roche Builds Quality Risk Management Program in Response to Viracept Crisis
This article was originally published in The Gold Sheet
Executive Summary
Roche's QRM program forged in crisis after Viracept recalled from AIDS epidemic in Africa due to GMP snafu. Upper management promised EU regulators a global review, called QuaSar. Massive effort involved training thousands of workers on how to assess risks and performing 100,000 FMEA risk assessments in just the first year. How Roche addressed the risks identified, replacing machines and even whole facilities when deemed necessary. How Roche transitioned to the proactive post-crisis second phase of its QRM program. The problem with doing FMEAs on Excel spreadsheets.
You may also be interested in...
The Quality Lowdown: New Valsartan Lessons, The 'White Hairs’ Who Remember Viracept
Why EU challenged Huahai’s valsartan quick fix, how FDA is making a lesson of Huahai, and what happens when examples like the Viracept recalls fade from memory – it’s all in this week’s Lowdown. Plus how Atlas is purportedly assuring sterility on Carefree Highway, and what happened when Sun used out-of-specification exhibit batches.
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.
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.