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Comparison of Various Requirements of the Quality Assurance Procedures for ¹⁸F-FDG Injection*

Nuclear Medicine, Department of Radiology, Mayo Clinic, Rochester, Minnesota

The quality assurance (QA) requirements (i.e., test procedure, acceptance criteria, and testing schedule) for fludeoxyglucose ¹⁸F (¹⁸F-FDG) injection listed in the U.S. Pharmacopeia (USP); the draft Chemistry, Manufacturing, and Controls (CMC) issued by the U.S. Food and Drug Administration (FDA); and the European Pharmacopeia (EP) were compared. The FDA Modernization Act of 1997 requires that the QA of compounded PET drug products be in compliance with the PET compounding standards and official monographs included in the USP. However, the "sunset" clause of the PET section within the FDA Modernization Act of 1997 stipulates that all PET drug products, in due course, must meet the requirements for drug approval procedures and current good manufacturing practice, and the FDA has issued a draft CMC that includes QA specifications for ¹⁸F-FDG injection. The purpose of this article is to discuss the pros and cons of each of the QA tests stated in the USP, CMC, and EP and to propose a practical testing method for each required test, thereby helping end users to ensure the quality of the ¹⁸F-FDG injection product. It is hoped that this article will stimulate further cooperation among various countries worldwide in the development of a set of harmonized and sensible QA standards for all PET drug products.

Key Words: ¹⁸F-FDG injection • quality assurance • U.S. Pharmacopeia • Chemistry, Manufacturing, and Controls • Food and Drug Administration • European Pharmacopeia