TGA

GxP What-is-GxP-acronym-definition

What is GxP compliance?

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 …

egal-cases-opioid-crisis-settlements.

Opioid Crisis (Legal Cases)

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 …

COVID-19-impact-on-Pharmaceutical-Manufacturing

Impact of COVID-19 on Pharmaceutical Manufacturing

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 …

TGA-Infringement-Notices-on-a-Vertiginous-Rise

TGA Infringement Notices on a Vertiginous Rise

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 …

pupsit

Pre-use Post Sterilisation Integrity Testing – PUPSIT

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 …

exporting-medicinal-cannabis

Exporting Medicinal Cannabis from Australia to Germany

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 …

software-as-a-medical-device

Software as a Medical Device (SaMD)

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 …