As many in the pharmaceutical industry know, the TGA has strict rules on advertising therapeutic goods. These rules are outlined via the Therapeutics Goods Advertising Code as well as guidance provided in Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG) During the Australian Medicinal Cannabis Conference, the TGA were questioned on their approach to illegal…
Many heralded the TGA’s proposal to downschedule low-dose cannabidiol (CBD) to S3 as groundbreaking, however, as I’ve covered in a previous blog, there are additional complications that need to be addressed. The TGA’s initial safety review made recommendations for the dose of S3 CBD to be limited to 60mg/day, which received a fair amount of…
PharmOut is delighted to announce that Eleanor Redding has been promoted to the role of Senior Consultant. Eleanor has over 20 years’ experience in the pharmaceutical industry and specialises in quality management systems, compliance and technical document writing. She has worked in a wide range of roles during her career with experience in manufacturing, quality…
On 1 January 2021, ANVISA, Brazil became the 54th member of PIC/S. Like all other PIC/S members, both ANVISA and Brazil’s pharmaceutical industry will realize a wide range of benefits of PIC/S membership, particularly at this time of the Covid-19 pandemic when on-site GMP inspections of local and foreign sites have been curtailed substantially. The…
The first references to the term “dedicated facility” appeared in GMP literature in the early 2010s in response to potential cross contamination risks of manufacturing toxicologically sensitive products in shared facilities. The WHO Technical Report Series, No. 957, 2010 ‘Annex 3 WHO good manufacturing practices for pharmaceutical products containing hazardous substances’ specifies that “production of…
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