ARSAC

The Administration of Radioactive Substances Advisory Committee (ARSAC) advises UK health ministers and issues the licences required before radioactive substances may be administered to humans. Under the Ionising Radiation (Medical Exposure) Regulations 2017 — IR(ME)R — two licences are needed: an employer licence covering the organisation, its facilities and its governance, and a practitioner licence held by the named individual who justifies each exposure. Licences are procedure-specific, with defined diagnostic reference levels and maximum activities.

ARSAC sits alongside, not instead of, the other UK controls on a nuclear-medicine or radiopharmacy operation: MHRA manufacturing authorisation or Section 10 exemption for preparation, the Environmental Permitting Regulations for radioactive waste, IRR17 for worker protection, and GMP Annex 3 for radiopharmaceutical manufacture. A PET or generator-based radiopharmacy is therefore running a GMP process, a radiation-safety regime and a clinical-justification regime against the same batch.

That convergence is what makes short-half-life production hard to document. V5 Ultimate timestamps every step against activity decay, binds e-signatures to preparation and QC release inside the usable window, enforces calibration of dose calibrators and environmental monitoring before a batch can start, and holds the administration record against the ARSAC-licensed procedure — so audit evidence is generated live rather than reconstructed after the product has decayed. See radiopharmaceutical manufacturing software.