TGA Updates: New Pathways, Rule Changes, and Updated Application Requirements The Therapeutic Goods Administration (TGA) has implemented several changes that will take effect on 1 July 2024. Read on to determine whether any of these TGA updates could impact your products. Additional Pathway for Medical Devices that are Programmed or can be Programmed/Software as a…
The 2024 Pharma & Device Forum was held on May 23-24 at the Melbourne Convention & Exhibition Centre (MCEC) in Victoria, Australia. This was an important gathering of pharmaceutical manufacturing and medical device industry professionals including business owners, quality managers, operations experts, product developers and cleanroom engineers. This is a “for industry, by industry” life…
When budgeting for personnel to attend conferences and networking events, decision-makers often prioritise costs and potential downtime over the long-term benefits. However, investing in professional development (PD) opportunities for life science professionals can lead to significant productivity gains and financial returns. Professional Development is best viewed as an ‘uptime’ opportunity vs a ‘downtime’ event. That’s…
Australia is set to make a significant step in enhancing the safety and efficacy of medicinal products, active pharmaceutical ingredients (APIs), and sunscreens with a planned update to its manufacturing principles. As of 3rd June 2024, the country will transition to PIC/S Guide to GMP – 1 February 2022, PE009-16, with exclusions from Annexes 4,…
In the intricate realm of pharmaceuticals, where precision and safety are paramount, the FDA’s “Quality Considerations for Topical Ophthalmic Drug Products Guidance for Industry” serves as a beacon. Topical ophthalmic drugs play a pivotal role in managing ocular conditions, ranging from infections to glaucoma. Ensuring the quality of these products is not just a regulatory…
Available either in print or online, the Australian Government Style Manual was created by the Australia Public Service Commission and is a reference that directs technical document writers in the appropriate use of language, such as use of spelling (especially those American Z’s), grammar, punctuation and writing conventions. It is also equally useful for scientific…
The definition of technology transfer (TT) may vary depending on the type of TT. It is generally referred as bridge between academia and industry, though it may also involve transfer of knowledge within the industry. In the pharmaceutical industry, TT would very often include transfer of new product and process from development to manufacturing. It…
On January 31, 2024, the U.S. Food and Drug Administration (FDA) introduced a significant regulatory update through the issuance of the final rule for the Quality Management System Regulation (QMSR). This rule is aims to align the existing United States’ Quality System (QS) Regulation, as outlined in 21 CFR 820, with the internationally recognized ISO…
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