www.fdanews.com/articles/145725-final-guidance-calls-for-yearly-media-fills-for-pet-drug-aseptic-personnel
Final Guidance Calls for Yearly Media Fills for PET Drug Aseptic Personnel
April 18, 2012
All personnel involved in aseptic manufacturing of positron emission tomography (PET) drugs should participate in at least one media fill per year, according to final FDA guidance. The guidance replaces a September 2011 draft and, other than that recommendation, largely mirrors the previous version.
Washington Drug Letter
Washington Drug Letter