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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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Complaints & recalls

It is expected that all suspected or serious adverse reactions related to sterile radiopharmaceuticals labelled with fluorine-18 will be reported to the TGA.

In addition, in circumstances where the manufacturer is made aware of any quality issue that would have resulted in recall of products these events are reported to the TGA recalls coordinator, irrespective of whether any units are recoverable, e.g. following identification of retrospective sterility testing failures or significant environmental monitoring excursions that indicate an unacceptable risk to process integrity or product quality.

Recall actions should follow the guidance given in the Uniform Recall Procedure for Therapeutic Goods (URPTG). Related guidance is also provided in Compounded medicines and good manufacturing practice (GMP).

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