PAST: RPS COMMUNITY OF PRACTICE: GMP – a moving target

“GMP – A Moving Target”

Dr Doug Smyth, Molecular Imaging & Therapy Research unit (MITRU), South Australian Health & Medical Research Institute (SAHMRI)

Meeting Date/Time: March 24, 2026, 14:00 ESDT

Dear Colleagues
It gives me great pleasure to announce the COP lecture for March 2026, a presentation by Dr Doug Smyth. This will be
the first of two presentations focusing on the GMP regulatory environment. A second presentation on this topic (to be
announced soon) will be presented in April’s COP meeting.
Yours Sincerely
Andrew Katsifis
Chair ACPSEM-Specialty Group

Abstract
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) continually review and update Chapters and Annexes of
PE009 Guide to Good Manufacturing Practice for Medicinal Products (Guide to GMP). The current PIC/S Guide to GMP is
version 17, entered into force on 25th August 2023. However, Australia does not automatically adopt the current version
of PIC/S Guide to GMP as the legal standard of GMP in Australia. From 1 September 2025, the PIC/S Guide to GMP version
17 now applies to the manufacture of medicines, APIs and sunscreens supplied in Australia, unless exempt under
provisions in the Therapeutic Goods Act 1989 (the Act). The only changes resulting from the adoption of version 17 of
the PIC/S Guide relate to updates to Annex 1 for the manufacture of sterile medicinal products. All other aspects of the
GMP guide remain the same. The TGA issued a document in August 2025 outlining the significant changes to Annex 1
and expectations for full implementation by manufacturers by 01 March 2026.
This presentation will focus on the significant changes in Annex 1 of version 17 of the Guide to GMP and highlight the
future changes coming down the pipeline.

Introducing Dr Smyth
Dr Doug Smyth has held the position of QA Manager at SAHMRI MITRU since 2015. SAHMRI MITRU is a TGA licensed
manufacturer of [18F]FDG and is the home of Adelaide’s first and only cyclotron facility. Prior to joining SAHMRI, Doug
worked as a Radiochemist and Senior Radiochemist at the Royal Adelaide Hospital Nuclear Medicine Department from
2004.