But there’s also a serious point to the article, and Quinn outlines the role of BioPhorum’s Drug Substance Raw Material Variability Workstream and its recent A Holistic Approach to Raw Material Risk Assessments Through Industry Collaboration paper published September 2019.
The paper provides an aligned industry perspective on the risks associated with raw material qualification and a step-by-step, adaptable method to assess raw material risk. It is a comprehensive, practical working tool that does not demand exhaustive resources to prioritize proportionate risk effectively and efficiently.
Even Eeyore would be impressed…
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