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Manufacture of sterile radiopharmaceuticals labelled with fluorine-18

Interpretation of the PIC/S guide to GMP

11 February 2019

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Investigational medicinal product manufacture

Annex 13 - Manufacture of investigational medicinal products, is applicable to manufacture of sterile radiopharmaceuticals labelled with fluorine-18 where the product is intended for use as an investigational medicinal product, (IMP).

Manufacture investigational medicinal products in accordance with the PIC/S Guide to GMP, but note that there is an exception for the manufacture of IMPs when used in initial experimental studies in human volunteers. Take into account other guidelines where relevant and as appropriate to the stage of development of the product.

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