Australian GMP — Manufacturing Principles (PIC/S Guide)
Australia enacts GMP by reference: the **Therapeutic Goods (Manufacturing Principles) Determination 2020**, made under the Therapeutic Goods Act 1989, adopts the PIC/S Guide to GMP as the Manufacturing Principles a licensed manufacturer must meet. The current compilation (F2025C00920, in force 1 September 2025) pins **PE 009-17 of 25 August 2023**, excludes Annexes 4, 5 and 14, and — the provision that actually changes practice — makes the Guide’s “should” statements mandatory unless the manufacturer can justify departure to a TGA officer.
What this does not cover
stated in the document's own scope- Adopts the PIC/S GMP Guide for medicines; medical devices follow a separate conformity-assessment framework under the Therapeutic Goods Act.
- Sets manufacturing GMP via the Manufacturing Principles, not the product-registration decision on the Australian Register of Therapeutic Goods.
- Is the adopted GMP standard, not the TGA’s procedural guidance on how licence and clearance applications are made, which sits in separate documents.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
Australia’s GMP requirement is delivered by adopting the PIC/S Guide to Good Manufacturing Practice (PE 009) as the country’s legally binding Manufacturing Principles. Rather than writing a separate national GMP text, the TGA determines the PIC/S Guide to be the Manufacturing Principles that a licensed medicine manufacturer must meet. This makes the harmonised PIC/S GMP — which mirrors EU GMP — the operative standard in Australia. TGA manufacturing licences for domestic sites and GMP clearance for overseas manufacturers supplying the Australian market are both built on this PIC/S baseline.
Scope & applicability
Manufacture of therapeutic goods supplied in Australia, split into two regimes by Schedule 1. Part 1 covers therapeutic goods other than blood, blood components and haematopoietic progenitor cells, and applies the PIC/S Guide. Part 2 covers blood, blood components, HPCs and biologicals that do not contain live animal cells, tissues or organs, and applies the Australian Code of Good Manufacturing Practice instead.
Legal basis & how it acquires force
The Manufacturing Principles are determined under the Therapeutic Goods Act 1989: the relevant Determination adopts a specified version of the PIC/S GMP Guide as the principles to be applied in the manufacture of therapeutic goods. That Determination gives the PIC/S text the force of law in Australia. A domestic manufacturer holds a licence conditioned on compliance; an overseas manufacturer obtains GMP clearance, by which the TGA accepts evidence of compliance with the same standard — so the PIC/S Guide is not advisory here but the enacted requirement.
Document structure
| Part | Covers |
|---|---|
| Determination of Manufacturing Principles | The legal instrument adopting a specified version of the PIC/S GMP Guide |
| PIC/S GMP Guide — Part I | Basic requirements for medicinal products (the adopted core text) |
| PIC/S GMP Guide — Part II | Basic requirements for active substances used as starting materials |
| PIC/S GMP Guide — Annexes | The annexes covering sterile products, computerised systems, qualification and validation, and more |
| Licensing and GMP clearance framework | How the TGA licenses domestic sites and clears overseas manufacturers against the adopted standard |
Quick reference · What the Determination changes about the PIC/S Guide
Australia does not write its own GMP text; it enacts PIC/S by reference. But the enacting instrument is not a neutral wrapper — it edits scope and it changes the force of the word “should”.
- The adopted version is pinned — PE 009-17 of 25 August 2023, as in force at 1 September 2025 — a fixed reference, so a later PIC/S release does not become Australian law until the Determination is amended
- Three annexes are excluded — Annex 4 (veterinary medicinal products other than immunologicals), Annex 5 (immunological veterinary medicinal products) and Annex 14 (products derived from human blood or plasma) are carved out of the adopted text
- Voluntary annexes do not bind — A procedure or requirement in an annex identified as voluntary is outside the “applicable procedures and requirements” that must be complied with
- “Should” is mandatory by default — Every “should” in the PIC/S Guide must be followed unless the manufacturer satisfies a TGA officer that omitting it — or the alternative adopted — increases neither the risk of harm nor the risk of failing an applicable standard or condition, and departs from no record-keeping requirement
- Blood and HPCs follow a different code — Blood, blood components, haematopoietic progenitor cells and biologicals without live animal cells follow the Australian Code of Good Manufacturing Practice, where “should” is mandatory with no justification route at all
- A technical master file is required — Licence applications for blood, blood components or HPCs must include one; plasma is assessed against the EMA PMF Guideline (EMEA/CHMP/BWP/3794/03 Rev. 1)
The justification route is real but narrow: it runs to the satisfaction of a TGA officer, and it never reaches the record-keeping requirements.
Source: Therapeutic Goods (Manufacturing Principles) Determination 2020 (F2020L00864), compilation F2025C00920 as at 1 September 2025, ss. 4 and Sch. 1. Verify against the current text before relying on it for a submission.
Key requirements
- Comply with the applicable procedures and requirements of PIC/S PE 009-17 as adopted, excluding Annexes 4, 5 and 14
- Follow every “should” in the adopted Guide, or hold a documented justification that satisfies the three statutory tests
- Never justify a departure from a record-keeping requirement — that limb has no exception on either route
- Hold a manufacturing licence for an Australian site, or TGA GMP clearance for an overseas site supplying Australia
- Include a technical master file with any licence application for blood, blood components or haematopoietic progenitor cells
Implementation tips
- Check the compilation, not the instrument: the Determination is from 2020 but the adopted PIC/S version moves, and only the current compilation states which one is law today
- Build the “should” justification into your deviation and derogation process before an inspection asks for it — the tests are statutory and each limb must be met
- Do not assume the veterinary annexes apply in Australia; Annexes 4 and 5 are expressly outside the adopted text
- Australia has been in the scheme since its formation — accession to PIC in January 1993 and to the PIC Scheme in November 1995 — which is why the TGA can accept comparable overseas regulators’ evidence for GMP clearance
Revision notes
The Determination 2020 has been amended several times to move the adopted PIC/S version; the current compilation F2025C00920 has applied since 1 September 2025 and adopts PE 009-17 of 25 August 2023. The amendment carried a split commencement: the new text applies to manufacture from 1 September 2025, except that the incorporation of **Annex 1 clauses 2.1, 2.3, 7.14 and 9.31** applies to sterile manufacture only from **1 March 2026** — a deliberate deferral for the hardest contamination-control provisions.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Because Australia adopts PE 009 directly, its GMP is by construction harmonised with the other PIC/S participating authorities and, through PE 009, with EU GMP. Australia has been in the scheme since its formation: accession to the Pharmaceutical Inspection Convention in January 1993, and to the PIC Scheme in November 1995, the year PIC/S was established. Adopting the shared text is what lets the TGA accept evidence from comparable overseas regulators for GMP clearance. The adoption is by fixed reference rather than ambulatory, so the Determination must be amended for a newer PIC/S release to become law — which is why the compilation, not the instrument date, tells you which version applies.
TGA Manufacturing Principles: frequently asked questions
Quick answers to common questions about TGA Manufacturing Principles.
What GMP standard does Australia use?
Australia adopts the PIC/S Guide to GMP as its legally binding Manufacturing Principles under the Therapeutic Goods Act 1989. The current compilation of the Determination 2020 adopts PE 009-17 of 25 August 2023, excluding Annexes 4, 5 and 14.
Are the PIC/S Guide’s “should” statements optional in Australia?
No. The Determination makes them mandatory unless the manufacturer satisfies a TGA officer that omitting the requirement, or the alternative adopted, increases neither the risk of harm nor the risk of failing an applicable standard or condition — and departs from no record-keeping requirement.
How does the PIC/S Guide become law in Australia?
The TGA issues a Determination under the Therapeutic Goods Act adopting a specified version of the PIC/S GMP Guide as the Manufacturing Principles. That Determination gives the PIC/S text the force of law.
What is GMP clearance for overseas manufacturers?
It is the TGA process by which an overseas site supplying Australia demonstrates compliance with the same adopted PIC/S standard, often through evidence accepted from a comparable overseas regulator, rather than a separate domestic licence.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.