The U.S. Food and Drug Administration (FDA) has issued its final guidance on current good manufacturing practices (cGMPs) for PET radiopharmaceuticals.
The PET cGMP regulations contain "minimum standards for quality production of PET drugs at all types of PET drug production facilities," the document stated. "We have designed the cGMP regulations to be sufficiently flexible to accommodate not-for-profit, academically oriented institutions, as well as commercial producers."
The recommendations include guidelines for labeling and packaging, components and containers, handling and distributing PET drugs, and record keeping. The document is partly based on information from the U.S. Pharmacopeia (USP) general chapter on PET drug compounding.
Among the agency's recommendations is that newly installed equipment be qualified before first use to verify that it was installed correctly and is capable of operating as intended. In addition, the FDA recommends developing a preventive maintenance schedule with sufficient frequency to ensure the correct performance of the equipment.
The guidelines also recommend 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.
