We are aware of an issue causing the title of some ARTG entries to disappear. We are investigating as a priority and hope to have this resolved as soon as possible.
Purpose
This guidance explains TGA's interpretation and expectations for compliance by TGA licensed manufacturers of sterile radiopharmaceuticals labelled with fluorine-18 with the PIC/S Guide to GMP. This guidance document provides specific interpretation of PIC/S clauses, and how compliance may be met. Where no specific guidance is provided, full compliance with the requirements of the PIC/S clause(s) is expected.
Comply with the requirements of the marketing authorisation unless the medicine you manufacture is exempt from Part 3-2 of the Therapeutic Goods Act 1989.
In all cases, default standards apply to the manufacture of radiopharmaceuticals as defined under the Therapeutic Goods Act 1989.