Manufacturing’s True North: The Quality Compass
Quality needs to become more of a focus in biopharma organizations. Leaders should put manufacturing quality at the center of their competitive strategies and, therefore, inspire a culture of quality. The results will exceed the standards not only of regulators but also of patients, providers, and payers.
There are three major reasons why it is critical for executives to build a culture of quality: the high cost of quality failure, increased regulatory activity over the last 10 years, and the FDA’s changing approach to quality oversight. Life science companies have financial performance goals, but these goals are consistent with the need to have a focus on quality. Operational improvements will improve the quality of products and bring cost savings.
