Navigating the Latest TGA Amendments: Essential Information for Class IIa & Class IIb Medical Device Listings Ever since the shakeup of the European Union (EU) Medical Device Regulations (MDR) in 2017, the Therapeutic Goods Administration (TGA) have adjusted their dependence on utilising the EU as their basis for listing on the Australian Register of Therapeutic…
What were the changes? In 2021, ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring (2016) was updated, to become ISPE Good Practice Guide: Controlled Temperature Chambers Commissioning and Qualification, Mapping and Monitoring (Second Edition, 2021). The addition of “Commissioning and Qualification” to the title reflects the additional focus that these activities receive in…
Wholesaling of medicinal cannabis products involves the distribution of these products to various entities, such as Authorised Prescribers, pharmacies or other approved third-party outlets. If you are manufacturing medicinal cannabis products then you will likely be supplying them to Authorised Prescribers, pharmacies or other approved third-party outlets either in Australia or overseas. The process of…
What is a clean room? A cleanroom (GMP cleanroom), in my mind, is a combination of engineering design, fabrication, finish and operational controls (control strategy) that are required to convert a “normal” room to a “clean room”. This blog will attempt to explain the necessary characteristics of a regulated company clean room not producing potent…
Introduction For anyone involved in the manufacturing of sterile medicinal products, the recent PIC/S GMP version 17 Annex 1 guidelines are nothing short of a bible. They delineate the rigorous standards necessary to maintain product sterility. One such crucial aspect outlined in these guidelines is cleanroom monitoring. In this blog, we aim to elucidate the…
On 21 June 2023, PIC/S quietly published version 17 of its Guide to Good Manufacturing Practice for Medicinal Products (‘PIC/S GMP Guide’), PE 009-17 effective 25 August 2023. The sole substantive change being introduced with PE 009-17 is inclusion of the revised Annex 1 (Manufacture of sterile medicinal products), which was published in September 2022, after undergoing revision which was extensive in terms…
Medicinal Cannabis in Macedonia, recently formally renamed the Republic of North Macedonia, is booming. Cannabis business development in the region resembles similar trends we’re noticing in the global medicinal cannabis industry across the globe. See “Predictions for global medicinal cannabis industry growth (2020-2024)” and continue reading for information about cannabis business sectors in Macedonia/North Macedonia….
It might seem that changes to pharmaceutical regulations move at a glacial speed but, be assured, that they do move and they are happening. Back in August 2020 (you remember that year – you made a LOT of sourdough), Australia’s Therapeutic Goods Administration (the TGA) announced a consultation regarding amendments to the Poisons Standard. Amongst…
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