PIC/S Guide Update and Annex 16 Adoption: Navigating Australia’s Pharmaceutical Landscape

PIC/S Guide Update and Annex 16 Adoption: Navigating Australia’s Pharmaceutical Landscape

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,…

PIC/S GMP Guide PE 009-17 Quietly Published

PIC/S GMP Guide PE 009-17 Quietly Published

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…

Continuous Improvement – An integral part of the Pharmaceutical Quality System (PQS)
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Continuous Improvement – An integral part of the Pharmaceutical Quality System (PQS)

‘Continuous Improvement’ or ‘Continual Improvement’ within a quality system can be described as a process of ongoing improvement of products, services or processes through incremental and/or breakthrough improvements. Within the Pharmaceutical Industry, it’s important that companies ask themselves how continuous improvement has been built into the Pharmaceutical Quality System (PQS). The term may appear in…

Annex 2B – Manufacture of Biologicals under GMP PE009-015
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Annex 2B – Manufacture of Biologicals under GMP PE009-015

PE00-015 Guide to Good Manufacturing Practice for Medicinal Products has recently been adopted by the TGA in Australia. Notably, this update splits Annex 2 into Annex 2A: Advanced Therapy Medicinal Products and Annex 2B: Biological Medicines separately: Annex 2A: Manufacture of Advanced Therapy Medicinal Products for Human Use (ATMP) harmonises with the EudraLex Volume 4…