A02. Branch update: Manufacturing quality and GMP clearances
Tracks
GxP Principles
| Tuesday, June 3, 2025 |
| 11:15 AM - 12:15 PM |
| Pyrmont Theatre |
Chair & Speakers
Stephen Farrell
Director, GMP clearance
TGA, Manufacturing Quality Branch
Branch update: Manufacturing quality and GMP clearances
Abstract
The Manufacturing Quality Branch (TGA) assists in the timely supply of therapeutic goods, ensuring they are of appropriate quality for their entire lifecycle. This primarily relies on assessing manufacturers' compliance with Good Manufacturing Practice (GMP) principles for medicines, blood, tissues and cellular therapy products and conducting product recalls for all types of therapeutic goods. This session will provide an overview of the Branch's priority focus for the next 12 months.
GMP Clearances form a crucial part of the TGA’s evaluation of products to be registered or listed on the ARTG as well as ongoing surveillance activities of manufacturers and products throughout their lifecycle. The effect of the COVID-19 pandemic on global GMP inspections continues to affect the GMP Clearance Framework with increasing application numbers and complexity of evaluations. Learn about the key strategic objectives that continue to be delivered despite the current challenges as well as future plans to address the current backlogs.
The session will also feature a short panel session, giving attendees the opportunity to ask questions on any areas of interest.
GMP Clearances form a crucial part of the TGA’s evaluation of products to be registered or listed on the ARTG as well as ongoing surveillance activities of manufacturers and products throughout their lifecycle. The effect of the COVID-19 pandemic on global GMP inspections continues to affect the GMP Clearance Framework with increasing application numbers and complexity of evaluations. Learn about the key strategic objectives that continue to be delivered despite the current challenges as well as future plans to address the current backlogs.
The session will also feature a short panel session, giving attendees the opportunity to ask questions on any areas of interest.
Biography
Stephen is the Director of the GMP Clearance section of the Manufacturing Quality Branch and joined the TGA from industry in January 2016.
Prior to this, Stephen had over 10 years of experience in manufacturing facilities in both Europe and Australia across several categories of Therapeutic Goods including medical devices, biological drug substances, terminally sterilised and aseptic fill and finish operations and radiopharmaceuticals.
Stephen is also the chair of PIC/S Inspection Reliance Working Group leading efforts on increasing the use of GMP inspection reliance practices across PIC/S participating authorities.
