Tag: cyclotron compliance

Mar 31 2015

BioTrax QMS Enables Prestigious Cyclotron Facility to Improve FDA Compliance
The Situation The Cyclotron Radiochemistry Lab at Huntsman Cancer Institute is located on the University of Utah Campus in Salt Lake City. A concern about the efficiency of a paper based quality system was the driving force behind their search for an electronic solution. Representatives from Huntsman Cancer Institute turned to industry trade shows and […]
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Apr 16 2014

FDA Inspections: Did You Know?
When the FDA conducts an inspection at your manufacturing facility, will you be ready with the right documentation? In the last couple of years, operators of cyclotrons have been cited for serious deviations from the US Pharmacopoeia (USP) compounding standards and official monograph of Positron Emission Tomography (PET) drugs. Citations can be and are issued […]
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