Managing Risk in Raw Material Sourcing

Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.

Choosing excipients and suppliers for pharmaceutical formulations requires a clear understanding of product requirements; material properties; product, process, and material variability; and vendor practices. The goal is a safe, robust formulation that will meet bioequivalence and stability requirements, but also enable validatable manufacturing, explained Chris Moreton, consultant with FinnBrit Consulting, during a September 2016 webcast (1).

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