After Missteps, Novartis AG CEO Says Quality Matters
Published: Sep 05, 2012
For Novartis execs, the old cliche that ‘if it’s not one thing, it’s another,’ is becoming quite true. For the past year, the drugmaker has struggled to get a handle on manufacturing problems at several plants around the world, which have attracted scrutiny from regulators. The latest mishap occurred in Rosia, Italy, where a data-handling discrepancy caused some vaccines to be temporarily and voluntarily held for several months. The drugmaker undertook a so-called good manufacturing practice, or GMP, investigation and reported the findings to the European Medicines Agency and the Agenxia Italiana del Farmaco before shipments resumed two months ago, a Novartis spokesman confirms.