Brief

On 26/08/2025, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) issued an update regarding "Public Consultation Now Open: Revised GMP Guidelines". The PIC/S Guide to GMP is being updated with revised chapters on documentation and computerised systems, as well as a new annex on Artificial Intelligence. Public feedback is invited through stakeholder organisations or the European Commission website by 7 October 2025, with submissions directly to the TGA not accepted.

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Therapeutic Goods Administration (TGA)

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