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 …
Outdoor cannabis crop risks compared to indoor growing (protected cropping): What are the dangers and potential disasters of outdoor medicinal cannabis cultivation?
Outdoor medicinal cannabis cultivation may offer lower-cost production options for commercial-scale operators…but what …
Each year, the annual Greentech conference and exhibition brings together experts in the horticultural industry. Featured speakers at Greentech included top consultants in automated greenhouse designs, crop cultivation and GMP engineering, automation, light management, …
