Stephen Colgan, Senior Director in Global CMC at Pfizer Worldwide Research and Development is an advocate of lean stability testing, pointing out that the efficiency of stability testing can be greatly improved if we focus on the formulation’s weakest links. After all, why test the stability of a drug product when exposed to light when you already know from forced degradation studies that light will have no impact on the product’s stability or shelf life? And why take stability measurements at 3 and 6 months if you already know that the formulation is able to last at least one year? You are only creating more work for yourself, as well as for regulators, who have to assess all of the data. Lean stability strategies advocate that you only do what is scientifically relevant. Colgan tells us more – and why the industry is slowing taking steps to embrace the concept.
Stephen’s recommended publications: S. T. Colgan et al., “Opportunities for Lean Stability Strategies,” J. Pharm. Innov. 9, 259–271 (2014). S. Colgan et al., “Lean Stability,” AAPS Magazine, September (2015).
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