So says Kara Stockett Quinn of Merck & Co. In a recent American Pharmaceutical Review article, Quinn takes a light-hearted look at the role of raw materials in medicinal product manufacturing (and says “If A.A. Milne wrote of the hundred-acre biopharmaceutical facility, raw materials would inevitably play the role of Eeyore.”).
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…