What is a Unique Device Identifier (UDI)?
Unique Device Identifier (UDI) is a globally unique series of characters for each medical device on the market to:
Unambiguously identify a device for patient safety
Improve medical device traceability in the supply chains
The Unique …
Have you ever come away from an audit feeling unsure of your own organisational processes? Do you sometimes feel that your organisation is alone or unique in the types of audit deficiencies observed? How do you compare with others …
Industry support of overdose prevention
This is blog 8 of 10 Blogs in the overdose awareness and overdose prevention series.
What is GxP compliance? And how does GMP/GxP compliance help with overdose prevention efforts?
GMP and GxP are pharmaceutical-industry quality standards and …
Snapshot of the Opioid Crisis (Legal Cases)
This is blog 6 of 10 blogs in the overdose awareness and overdose prevention series.
International Overdose Awareness Day (31st August) is rapidly approaching. It warrants a discussion of the opioid crisis in the …
Faecal microbiota transplants are quickly gaining popularity around the world. If you have heard of FMT, chances are either you are not particularly squeamish or you have had enough time to digest the concept, pun intended. To put it …
How is the pharmaceutical manufacturing industry around the world expected to continue production during the COVID-19 pandemic? What control measures should be in place to help prevent or mitigate the potential adverse effects of COVID-19 on the safety and …
It’s probably apparent to most of us right now that disaster brings out both the best and the worst in humankind.
Healesville, VIC thanks essential workers. Credit: E. Redding
Take heart in the incredible acts of kindness reported daily as …
What is Pre-use Post Sterilisation Integrity Testing (PUPSIT)?
PUPSIT stands for pre-use post sterilisation integrity testing. PUPSIT is performed once your sterilising filter is installed to ensure that the sterilisation and installation process has not damaged your sterilisation filter prior …
With the legalisation of cultivation and export of medicinal cannabis products within Australia, many growers and companies producing medicinal cannabis products have set their interest in exporting their excess products to other parts of the world.
A market of particular …
SaMD: A need for Regulatory Reform in Australia
In February 2019, the TGA issued a consultation for feedback from industry on how Software as a Medical Device (SaMD) is regulated in Australia. Currently, SaMD is regulated under the existing medical …
