FDA Issues Guidance on PET Radiopharmaceutical Manufacturing Processes
A final guidance on current good manufacturing practices (cGMPs) for PET radiopharmaceuticals has been issued by the U.S. Food and Drug Administration (FDA). Included in the recommendations—which the agency based in part on information from the U.S. Pharmacopeia (USP) general chapter on PET drug compounding--are guidelines for handling and distributing PET drugs. Guidelines pertaining to labeling and packaging, components and containers, and record keeping are provided as well. The agency recommends that newly installed equipment be qualified before first use to verify that it was installed correctly and can be operated as intended. It also counsels manufacturers to develop a preventive maintenance schedule with sufficient frequency to ensure correct equipment performance. The guidelines also incorporate the recommendations that PET drug production facilities have adequate ongoing programs or plans in place to train employees in new procedures and operations and in areas where deficiencies have occurred. To read the guidance, click here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM266640.pd.