Sometimes, designing and building manufacturing facilities can feel a bit like you’re on a merry-go-round.
“Round, round…” and dare I say it “…right round like a record, baby…”
Though obviously cringing at my long-drawn 80’s bow, …
The Department of Health (DoH) recently released a report that reviewed and reported on barriers encountered by patients when trying to access to medicinal cannabis in Australia. There are many contributors who will understandably …
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 …
The EU Medical Device Regulation (MDR) is the most significant regulatory change in Europe in over 20 years. The MDR will replace the Medical Device Directive 93/42/EEC, effective 26th May 2020. The MDR entered …
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 …
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 …
Unlike other markets (i.e. Canada, the US, the UK and parts of Europe) CBD is more strictly controlled in Australia, and the pure extracts (as well as any associated products) are considered Schedule 4 …
What is the Medical Device Single Audit Program (MDSAP)?
The Medical Device Single Audit Program (MDSAP) was launched by the International Medical Device Regulators Forum (IMDRF) in 2014 as a pilot program, satisfying the requirements …
Recent presentations given about South African Medicinal Cannabis
CannaTech and Sandton Cannabis Expo 2019
During the month of November 2019, the PharmOut team attended the CannaTech Conference in Cape Town, South Africa for 2 days to …
Quality Management System software providers have matured in recent years, with an increasing number entering the Pharmaceutical and Medical Device industries and marketing themselves as 21 CFR Part 11 and ISO 9001 compliant.
The fact …
