Outdated Australian GMPs – Should we be doing more to protect our “brand Australia”?
As the gap between current EU/PIC/S GMPs and Australian GMPs widens is the TGA losing relevance?
Last week when I was speaking with a Senior Quality Executive from a leading Australian pharmaceutical manufacturer, I was surprised when they stated that they no longer prioritised TGA inspections or findings. This is in stark contrast with my professional belief and experiences and caused me to examine how and why a leading Australian pharmaceutical manufacturer would perceive TGA GMPs in this light?
The TGA adopted internationally harmonised manufacturing standards, PIC/S Guide to Good Manufacturing Practice – 15 January 2009, PE 009-8, to be the mandatory Code of GMP for Australia (except for Annexes 4, 5 and 14) in 1 July 2010.
It was a significant change for Australian manufacturers of medicinal products with the most significant being:
- the requirement to prepare periodic Product Quality Reviews (PQR)
- introduction of quality risk management (QRM)
- detailed procedures on stability testing and on reference and retention samples,
- several changes for the manufacture of sterile medicinal products (Annex 1).
The TGA website states that ‘The TGA uses internationally harmonised manufacturing standards to allow manufacturers to operate in an international environment, ’ and ‘Australian manufacturers benefit from reduced regulatory burden where the TGA is able to adopt harmonised international standards and establish mutual recognition agreements and cooperation arrangements with comparable overseas regulatory authorities.’
What happens if Australia falls behind international standards?
Jump forward six years…
PIC/S issued version 12 of their Guide to Good Manufacturing Practice and are working on version 13, whilst Australia remains legislated to follow a very old version 8. With each PIC/S version update Australia falls further behind.
Version 12 has bought PIC/S into closer alignment with what is consider international best practice. It closely follows the EU GMP guidelines and actively incorporates ICH guidance into Annex 15-Qualification and Validation.
Each previous update has introduced nuances of change that Australian industry may need to one day adopt and possibly the patients of Australian manufacturers deserve.
What might be next?
According to the May 2015 PIC/S press release, Chapter 1, 2, 6 and 7 as well as Annexes 13 and 17 are in review. All we can be sure of is the gap between version 8 and international standards is going to get wider.
There is an inevitability around the TGA moving to a more current version of PIC/S, after all, this is what being part of the international harmonised community is about. Is it time for Australia to ‘bite the bullet’ and align with current PIC/S to ensure we stay harmonised with the international standards?
Going back to the starting point, the Quality Executive was by-passing TGA GMPs as they, as a company, believe the Australian manufacturing industry’s reputation exceptional quality is something they wish to protect.