Today the TGA just released a new medicinal cannabis GMP compliance guide titled “Guidance on GMP compliance for the manufacture of medicinal cannabis for supply under ‘approved access’ provisions“. Not sure there would be any experienced GMP consultant surprised by any of the updates, as expected the TGA continues to follow convention wisdom, a medicine is…
This quick clean room design checklist is part of a number of free suggestions, tools or tips put together by our (frustrated) staff to try circumvent a poor clean room design. 1. Stakeholder consultations Has everyone who has a stake in the clean room been consulted? This includes: Maintenance – ask them what will need…
Last week MTPConnect announced grants worth $7.4 million for 14 national projects supporting the growth of the medical technologies, biotechnologies and pharmaceuticals sector so all of the Australian life science research sector. This is an exciting announcement from the MTPConnect team, led by Sue MacLeman, CEO. The team appears to be driving hard since their formation as a…
Previously we wrote about the TGA planning to revise the complementary medicine guidelines. On the 13 October 2016 the Australian TGA released the sixth version of the Australian regulatory guidelines for complementary medicines ARGCM, Version 6.0, October 2016 this is is the fifth update of the Australian Complementary Medicine Guidelines since 2013. This is This short blog is to draw your attention to…
Yes. That old chestnut. Well, that is to say, the notion of “architecture as art” or moreover reframed as the simpler question “is architecture art?” has intrigued me for such a long time now – just as it has for many before me (and many to come I suspect) – as architecture seems to be…
With the increasing optimisation of value-engineering using Building Information Modeling (BIM) solutions for advanced pharmaceutical facility design, it has never been more critical to properly understand the existing conditions of buildings when working on ‘brownfield’ sites. And the most effective design solutions required of the process architect are those unquestionably aligned with a client’s business…
In recent years I’ve increasingly heard clients wanting state of the art pharmaceutical manufacturing plants or medical device manufacturing plants. Not fully understanding what this actual brief means, I have always asked for clarification, after all our company and our partners need to design, build and validate it. Obviously, this is a complex brief, I…
The recent scheduling changes to medicinal cannabis, which includes cannabidiol (abbreviated as “CBD”) and tetrahydrocannabinols (“THC”), moving it from Schedule 9 (prohibited substance) to Schedule 8 (controlled substance). This change, coupled with the rapidly evolving legislative changes around both cultivation and patient access to medicinal cannabis, have many Australian cultivator and manufacturing innovators on high…
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