Tue 2 September 2025
NSW Health and AdPha partner to improve patient care through safer preparation of personalised medicines
The Pharmaceutical and Advanced Therapeutic Production Credential provides education and training in aseptic production, including use of Sydney’s state-of-art Biologics Innovation Facility.
At a glance:
- Advanced therapeutics are innovative medicines based on genes, cells, or tissues that offer potential treatments for previously untreatable disease and injury, particularly rare diseases and conditions
- Aseptic production involves safely preparing personalised medicines in sterile conditions. Aseptically prepared products are high risk because they are often given directly into sterile areas of the body.
- Studies show that up to 1 in 103 aseptically prepared products have a level of measurable contamination.
- The new credential and training standards aim to equip health professionals with the skills needed to safely prepare these high-risk products.
- The Biologics Innovation Facility (BIF) at the University of Technology Sydney (UTS) will host the final in-person component of the credential, offering hands-on experience in a simulated environment.
NSW Health has renewed its partnership with Advanced Pharmacy of Australia (AdPha) to deliver targeted education and training for Australian healthcare workers involved in aseptic production, further strengthening the state’s capabilities in preparing pharmaceutical and advanced therapeutic products, to positively impact patient care.
This initiative builds on the success of the 2023 collaboration between NSW Health and AdPha, which delivered a foundational education package focused on governance in this emerging and complex area of practice.
The expanded partnership supports the implementation of the NSW Health Policy Directive: Preparation of Pharmaceutical and Advanced Therapeutic Products, which provides comprehensive guidance on safe and compliant preparation of these products across public health facilities.
With the rapid growth of advanced therapeutic products — including gene and cell therapies — pharmacists and technicians are increasingly required to manage a broader range of complex preparations. The policy sets out standards for both aseptic and non-aseptic preparation, ensuring compliance with key legislation including the Therapeutic Goods Act 1989 (Cth), Poisons and Therapeutic Goods Act 1966 (NSW), and other national regulatory frameworks.
To support this, the new Pharmaceutical and Advanced Therapeutic Production Credential has been developed as a robust, evidence-based training program. Delivered through a multi-modal learning approach, the credential ensures all practitioners are skilled in the safe preparation of these products, and operating to the highest professional standards.
The credentialed program is designed for pharmacists, technicians and healthcare personnel across Australia undertaking aseptic compounding or preparation of pharmaceuticals and advanced therapeutic products.
Quotes attributable to Dr Jean-Frédéric Levesque MD PhD FRCPC, Deputy Secretary, Clinical Innovation and Research Division, Ministry of Health and Chief Executive, NSW Agency for Clinical Innovation:
'NSW Health has developed a credentialling program for advanced therapeutics that is now being rolled out nationally by the peak body, Advanced Pharmacy Australia – demonstrating the state’s leadership in setting standards for the safe delivery of these innovative treatments.
‘The Pharmaceutical and Advanced Therapeutic Production Credential program opens up opportunities for regional practitioners to deliver therapies and conduct clinical trials within their communities. The hybrid model combines online learning with two days of hands-on training at the Biologics Innovation Facility, a state-of-the-art training location.’
Quotes attributable to AdPha Vice-President and NSW Board Director, Dr Kate O’Hara FANZCAP (Neonatol., Paeds):
‘We’re pleased to deepen our collaboration with NSW Health, reflecting our shared commitment to elevating pharmacy practice through comprehensive training, which will be available to practitioners across Australia.
'This new credential is an important step toward maximising the safe administration of these complex medicines, for those who need them.’
Quotes attributable to Office for Health and Medical Research (NSW Health) Project Lead, Kerry Watts FANZCAP (Compound., Research).
‘The new credential program is rigorous, because we must get this right.
'Pharmacy production involves high-risk processes where precision and quality control are critical. A dedicated credential helps reduce the risk of contamination and strengthens our health system’s preparedness to deliver advanced therapeutics to patients safely and effectively.’
The Pharmaceutical and advanced therapeutic production credential includes staged learning of over 35 hours:
- Core content covering 19 topics
- Portfolio of assessments
- Elective selection
- Live virtual workshop
- Live two day in-person training at the Biologics Innovation Facility (BIF) in Sydney
- Workplace based assessments
All content is accredited and includes Group 2 CPD activities, with over 70 Group 2 CPD credits available.