PET Drug Aseptic Personnel Should Do Media Fills Yearly: Final Guidance

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. Media fills that test whether aseptic procedures are adequate to prevent contamination during the production of PET drugs should ensure they are representative of all aseptic manipulations, the final guidance states.
Drug GMP Report