QRM Not the Same as Root Cause Analysis
This article was originally published in The Gold Sheet
William Miele of Pfizer Global Manufacturing discussed the differences between quality risk management as espoused under the ICH Q9 guideline and root cause analysis at the 11 APIC/CEFIC European conference on APIs Oct. 23 in Paris. He said that "root cause analysis is retrospective, examining what has already occurred to determine what happened, why it happened and how it can be prevented from happening again. Risk management looks at the dataset and what are the potential future consequences and identifies potential risks and analyzes potentials risks; these actions are all focused on making decisions related to potential future events." He also noted that QRM "is a tool to complement existing works processes" and that "the primary outputs of QRM are decisions to identify the actions needed to controls risk.
You may also be interested in...
The US FDA has proposed moving two categories of hepatitis C diagnostics to class II from class III because they pose relatively low risk.
As the US heads into a COVID-19 storm with grave concerns about the lack of face masks and respirators for health care workers, the FDA has further relaxed federal oversight for such products, giving more responsibility to employers
FDA made request after finding unacceptable levels of nitrosamine NDMA can form during storage above room temperature or beyond expiry. Forthcoming guidance on detecting impurities like nitrosamines in any drug will call for routine testing as well as a chemical risk assessment “to look at what is the probability of generating them.