PDA Letter Article

Five Keys to Manufacturing Success

by R. J. Filannino, Alice Redmond, and Richard Tree, Commissioning Agents

Commercializing GMP products requires tremendous organizational learning. This conflicts with the regulatory and business drivers that force product development down a fast-paced, restrictive path. Knowledge transfer is rarely a priority. Short-term motivators end up taking precedence over long-term organizational development. As a result, manufacturers find themselves without sufficient knowledge to consistently supply quality product. Organizations that are functionally balanced and can transform knowledge into organizational learning will be the ultimate winners in achieving greater manufacturing flexibility (1).