PAST: RPS COMMUNITY OF PRACTICE: Practicalities of GMP in Radiopharmacy

Practicalities of GMP in Radiopharmacy

Continuing from last month’s theme on Quality and GMP, Gemma Maguire will be presenting the RPS COP lecture for April 2026. This will be the second of two presentations focusing on the GMP regulatory environment with Gemma focusing on the practicalities of implementing the latest TGA updates to Annex-1.

Join online via Microsoft Teams with the event location link.

Passcode: JM2M3f4v

Abstract

PE009, the PIC/S Guide to Good Manufacturing Practices (GMP), is designed for the industrial and commercial manufacture of medicinal products and represents the regulatory gold standard applied by the Therapeutic Goods Administration (TGA) for licensed manufacturing activities. While licensing exemptions exist under the Therapeutic Goods Act (1989) for public hospital radiopharmacies, limited guidance is available on suitable quality systems within this exemption space. This presentation will focus on the practical challenges of meeting GMP requirements to achieve and maintain a TGA manufacturing license in a public health radiopharmacy, and balancing “GMP-like” manufacturing in the same facility. This presentation aims to promote open discussion on GMP expectations and whether an alternative may offer a more appropriate approach such as PE010 PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments.

Biography

Gemma Maguire is a radiochemist and leads Quality Assurance at Q-TRaCE, a radiopharmacy embedded in the Department of Nuclear Medicine at the Royal Brisbane and Women’s Hospital. Quality Assurance oversees all validation and manufacturing activities across the facility and works with both clinical and research teams to deliver safe and efficacious products to patients across QLD public hospitals.