The initiative is designed to improve the quality of audits for materials and supplies, such as active pharmaceutical ingredients, chemicals used in quality control, and accessories in direct contact with radiopharmaceuticals or their ingredients before application. The latter category would include tubes, syringes, cassettes, and primary packaging materials.
"It is expected by the regulatory bodies that the manufacturer of radiopharmaceuticals should perform regular audits at least for the suppliers of critical starting materials," the EANM wrote about SASAI. "Therefore, multiple institutions across Europe are being requested to perform audits on the same suppliers, usually independently and in a noncoordinated manner. In addition, radiopharmaceuticals are often manufactured by small institutions or universities that in most cases do not have the staff resources and financial means to perform these audits regularly if at all."
Under the EANM's plan, qualified auditors would collect the data and create a report, which would be available for a service fee.
The EANM would like to hear from interested parties before 31 May.
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