Fajar Dumadi
Regulatory Program Specialist
ISCT Head Office
The TGA's Good Manufacturing Practice (GMP) Forum was held in Sydney on 21 March 2023 at the International Convention Centre in Darling Harbour. The GMP Forum 2023 provided participants with the opportunity to connect with the TGA and learn from TGA’s GMP subject matter experts. The forum featured a variety of plenary sessions, break-out sessions, workshops, and exhibition stations and concluded with a networking event.
In his welcome and opening remarks, Dr. John Skerritt, Deputy Secretary for Health Products Regulation Group, Department of Health and Aged Care, TGA, mentioned that as of June 2022, there were 265 Australian companies holding manufacturing licenses covering 410 sites. The COVID 19 vaccine production demands has increased the need for rapid expansion of global manufacturing capacity, causing the following challenges:
- Increased reliance on Contract Manufacturing Organisations – New relationships and jurisdictions as well as limitations in the number of CMO’s available
- Supply chain constraints – Limitations in suppliers of raw materials
- Technology transfer – Several sites around the world are being brought online together
- Cross contamination – Multiple products manufactured in the same facilities
- Public Scrutiny – increased pressure on manufacturers to deliver
Furthermore, it was noted the COVID-19 pandemic has caused a GMP ‘hangover’. Years of international travel restrictions have resulted in a large number of manufacturers requiring inspections, thus impacting all regulators (application volumes, work on hand and target timeframe continue to increase).
Although there were options to perform the inspections either remotely or hybrid, each audit type offers its benefits and challenges. Therefore, a robust adherence to GMP principles is needed to mitigate many of risks caused by those challenges.
One of the alternative inspection models is GMP inspection reliance. Through this model the TGA can perform a desktop audit while incorporating evidence from “Recognised Regulatory Authorities” or RRA for overseas manufacturing sites. This model, however, is dependent on the level of equivalence between TGA and RRA and the availability of mutual recognition agreements/other arrangements in place. Therefore, TGA still needs to:
- Better document rationale for acceptance of RRA GMP inspections and have a transparent framework for assessing new and existing partners.
- Determine whether third country inspections by RRAs can be in scope for GMP Clearances
- Plan to develop and communicate a “GMP Inspection Reliance Framework” in 2023-24
Dr. Skerrit also highlighted some GMP issues found during the manufacturing stage. In cell and tissue manufacturing particularly, scale up from clinical trial scale to commercial scale can be challenging, especially for clinical trials.
You can access and download the presentation from all sessions here.
References:
GMP Forum 2023, https://www.tga.gov.au/resources/event/workshops/gmp-forum-2023, Published on 21 March 2023, Accessed by 24 April 2023.
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