GMP Auditing & Consulting LLC — Reference Docket

TGA GMP Index (Australia)

Australia's Therapeutic Goods Administration framework, built on direct legal adoption of the PIC/S GMP Guide, organized by product category — every entry links to its source. Search by keyword or PE 009 Annex.

— entries indexed PIC/S GMP PE009-17 applies from 1 Sep 2025

Overall Index

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A GMP Auditing & Consulting LLC resource.

This library maps Australia's therapeutic goods GMP framework to the product categories manufacturers build against. The TGA takes a distinctive approach among the bodies in this series: rather than publishing its own GMP text, section 36 of the Therapeutic Goods Act 1989 gives the PIC/S Guide to GMP (PE 009) direct legal force in Australia via the Manufacturing Principles Determination — currently PE009-17 (25 August 2023), applying from 1 September 2025, with Annexes 4, 5 and 14 explicitly excluded from Australian adoption. Three structural quirks worth knowing for client work: sunscreens are regulated as therapeutic goods in Australia (unlike almost anywhere else); cosmetics are explicitly not TGA-regulated, falling instead under the Australian Industrial Chemicals Introduction Scheme (AICIS); and medical devices use an EU-style four-tier Class I/IIa/IIb/III system rather than FDA's three classes. Citations link directly to tga.gov.au pages where confirmed. We review this library periodically as the TGA continues its PIC/S version updates. Corrections welcome at gmpauditingandconsultingllc@gmail.com. This index is a navigational aid, not legal or regulatory advice.