The recently released FDA guidance on current good manufacturing practice (cGMP) for PET drugs addresses resources, procedures and documentation expected of facilities, as well as distinguishes between PET drug production practice and pharmacy practice.
The FDA Modernization Act of 1997 directed the administration to establish cGMP requirements for PET drug production. Since the legislation, both the number of PET drug producers and the number PET scanning facilities have increased, according to the document.
Over time, increasing numbers of PET production facilities shifted from universities and nonprofit institutions to for-profit corporate entities, according to the FDA, but that shift has had “little bearing on the quality of PET drugs that it produces and distributes for administration to patients.”
The cGMPs were designed to be flexible to accommodate nonprofit and commercial producers, according to the guidance, while maintaining minimum standards for quality production of PET drugs. The guidelines also incorporate principles from the U.S. Pharmacopeia general chapter for PET drugs.
In distinguishing between PET drug production and the practice of pharmacy, the FDA determined that the production of a PET drug includes all operations to the point of final release of a finished dosage form. All of those activities will be subject to cGMP, the guidance noted. The FDA makes recommendations about appropriate personnel resources, quality assurance, facilities and equipment, production, labeling and distribution practices.
Click here for the full guidance.