Novartis Flu Vaccine Snafu Shows Need to Extend “Op Ex” to Contract Drug Manufacturing

If drug manufacturing efficiency varies inversely with the degree of manufacturing complexity, contract drug manufacturing and packaging operations must be the most complex of all.  Can they always be efficient? Contractors, after all, must adapt constantly to shifting products, clients, and key customer markets/regulatory requirements. Leading contract organiztions do what they do very well, but they may still slip up sometimes.  The latest evidence was reported on yesterday, when The Washington Post disclosed that Novartis had recalled  500,000 doses of flu vaccine after it was found that they had been frozen.  (Click here to read the story). This apparently took place when the vials were in the custody of its contract partner, Cardinal Health. Cardinal is looking into what might have caused the problem.  But it made me think that more drug companies should extend their in-house manufacturing excellence programs beyond their company borders---that they should have the same standards in place, and they should track performance regularly, and impose  penalties when standards aren't met. Not to suggest that there are structural problems at Cardinal, which has a very good record, or that Novartis isn't fully committed to op ex. But formal programs that do this are very difficult to start up and maintain.  It's hard enough to measure data and keep up with metrics at your own facility, and some contractors may resent too much supervision.  But it can be done. We reported recently on the work that one group at Wyeth was doing to set standards and ongoing metrics for its partners.  Are more efforts like this going on? Please write in and let us know. -AMS