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: The Unique Device Identifier of a medical device typically includes two parts: History of UDI The first concept of UDI was signed into US law and added as part…
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 with respect to audit deficiencies? Audit Deficiencies Reported by the TGA The Australian Therapeutic Goods Administration…
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? Compliance with manufacturing regulations (GMP/GxP guidelines): Accurate packaging and labelling information can help: Download the latest Australian overdose statistics report (2021)…
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 United States, a 20-year phenomenon where over 800,000 people have lost their lives to…
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 quality of products? In April 2020, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published…
It’s probably apparent to most of us right now that disaster brings out both the best and the worst in humankind. Take heart in the incredible acts of kindness reported daily as we recognise the sacrifices and risks that so many healthcare professionals, supermarket workers and delivery drivers are taking to keep the rest of…
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 to filtration of your product. What do the regulations say? PUPSIT was first introduced to…
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 interest is Germany, in which 60,000 patients registered for medicinal cannabis products in 2019, which…
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