BIO 2008: What? FDA STILL hasn’t been accepted into The Pharmaceutical Inspectorate?

At a session on Wednesday afternoon, Richard Friedman of CDER discussed FDA and foreign inspections of manufacturing sites, and mentioned proposed solutions that would harmonize requirements and lighten the load, while maintaining standards.  They include a global system of surveillance and mutual inspectorate acceptance.  In this plan, FDA and EU inspectors who had inspected certain facilities would share reports with inspectors from nations in the rest of the world, in lieu of onsite inspections.  It would involve expanded use of certificates of pharma products and use of risk-based models outlined in ICH Q9.  Triggers would include facility size, recent history…outdated information, time since last inspection, product risk (e.g. sterile products would require more requent inspections) and process risk (i.e. contamination). The EU and FDA have launched a pilot program for joint inspection of plants, to start by the end of this year, early next year. We’ve been following FDA’s Pharmaceutical Inspectorate for some time…was surprised to see that the Agency still hasn’t been formally accepted into PIC/S.  Come on, now!  It has been under discussion for two years now.   Wonder what this means?  AMS