Australian GMP — Manufacturing Principles (PIC/S Guide)
Australia adopts the PIC/S Guide to GMP (PE 009) as its legally-binding Manufacturing Principles, determined under the Therapeutic Goods Act. TGA licensing and GMP clearance for overseas manufacturers are built on this PIC/S baseline.
Manufacturers of therapeutic goods supplied in Australia, and overseas manufacturers requiring TGA GMP clearance.
- 01Comply with the adopted PIC/S GMP Guide
- 02Hold a manufacturing licence or GMP clearance
- 03Meet Annex 1 sterile expectations where applicable
The Manufacturing Principles are updated as the TGA adopts newer PIC/S PE 009 versions.
TGA Manufacturing Principles: frequently asked questions
Quick answers to common questions about TGA Manufacturing Principles.
What is TGA Manufacturing Principles?
TGA Manufacturing Principles — Australian GMP — Manufacturing Principles (PIC/S Guide) — is a regulation issued by the Therapeutic Goods Administration (Australia). Australia adopts the PIC/S Guide to GMP (PE 009) as its legally-binding Manufacturing Principles, determined under the Therapeutic Goods Act. TGA licensing and GMP clearance for overseas manufacturers are built on this PIC/S baseline.
Who does TGA Manufacturing Principles apply to?
Manufacturers of therapeutic goods supplied in Australia, and overseas manufacturers requiring TGA GMP clearance.
What are the key requirements of TGA Manufacturing Principles?
TGA Manufacturing Principles requires, among other things: Comply with the adopted PIC/S GMP Guide; Hold a manufacturing licence or GMP clearance; Meet Annex 1 sterile expectations where applicable.
When was TGA Manufacturing Principles last updated?
The current version of TGA Manufacturing Principles dates from July 2023. The Manufacturing Principles are updated as the TGA adopts newer PIC/S PE 009 versions.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When TGA Manufacturing Principles — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.