TGO 93 Cannabis Testing Limits: The QAP Reference for Australian Batch Release

TGO 93 is the quality bar every Australian medicinal cannabis batch must clear before it leaves the door, and the QAP signing the release is the one accountable when a limit is missed.

The Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 is the legal quality standard for medicinal cannabis in Australia. It sets the testing requirements a Quality Assurance Person (QAP) checks against on every batch release: cannabinoid content accuracy, mycotoxin limits, heavy metals, foreign matter, total ash, microbial limits, and the analytical method validation behind every reported number. This page is the working reference for QAPs who need the TGO 93 cannabis testing limits in one place, with the legal source, the typical Certificate of Analysis review checklist, and the gotchas that surface in TGA inspections.

For the wider picture, our Australian cannabis LP compliance checklist covers ODC licensing, PIC/S GMP v17, GACP cultivation, and ODC quarterly reporting alongside this TGO 93 deep-dive.

What Is TGO 93 and Which Cannabis Products Must Comply?

TGO 93 is the official quality standard for medicinal cannabis products supplied in Australia. The full title is the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017, made under the Therapeutic Goods Act 1989. The current compilation is F2022C01204, effective 6 December 2022.

One scheduling note every QAP should diary: TGO 93 is a sunset legislative instrument scheduled for repeal on 1 April 2027 under section 50 of the Legislation Act 2003. A replacement instrument is expected before sunset, so watch for transitional guidance on the Federal Register of Legislation. Until that happens, the current compilation governs every batch release.

The standard applies to medicinal cannabis products supplied under the unapproved-goods pathways: Special Access Scheme (SAS), Authorised Prescriber Scheme (APS), and clinical trials. It does not apply to industrial hemp food products or to recreational cannabis.

Three points QAPs sometimes get wrong about TGO 93 scope:

• It is in addition to GMP, not instead of GMP. A TGO 93 conformant batch from a non-GMP facility is still non-releasable. Product must come from a PIC/S GMP v17 (PE009-17) compliant manufacturer with a current TGA Licence to Manufacture Therapeutic Goods or equivalent overseas inspection.
• Cultivation alone does not require GMP. Growing, cutting, and drying may be done without GMP if material is used as a starting material for a GMP licensed facility. First crude extraction may also qualify. The TGO 93 testing burden sits with the GMP manufacturer, not the cultivator.
• Inhaled cannabis is in scope. Dried herb cannabis (flower) is a TGO 93 product. The standard treats inhaled and oral products under the same instrument, with limits that reflect the route of administration where relevant.

For the licence side, see ODC cannabis licence Australia; for the manufacturing-side GMP frame, see PIC/S GMP v17 cannabis Australia.

What Are the Specific TGO 93 Testing Limits for Cannabis?

The TGO 93 cannabis testing limits are the per-batch release numbers a QAP verifies on the Certificate of Analysis (CoA) before signing off. The table below lists the limits that are quoted verbatim in TGO 93 and have widespread agreement across published TGA guidance. For limits that vary by product matrix, route, or pharmacopoeia cross-reference (heavy metals in particular), the table flags the legal source rather than inventing a single number. A QAP should always confirm the applicable limit against the current compilation of TGO 93 and the manufacturer’s product dossier.

The QAP’s job on every batch release is to walk this table against the lot CoA and the batch record, confirm each attribute passes, and document the cross-check. Any limit missing from the CoA is a hold, not a release. Any limit reported by a method not listed in the manufacturer’s TGO 93 dossier is a hold, not a release. Conservative is faster than recall.

How Do You Verify TGO 93 Compliance on a Batch?

The standard a TGA inspector applies is documentary: did the QAP have the evidence in hand at the time of release, signed, dated, and traceable? The TGO 93 cannabis testing limits are the test, the batch record is the proof. The eight-point batch release routine below maps directly to the standard.

1. Identify the product category. Dried herb, oil, capsule, tincture, or other. TGO 93 contains category-specific provisions and applicable limits depend on which category the batch sits in.
2. Pull the manufacturer’s TGO 93 dossier. Validated analytical methods (with ICH Q2(R1) summaries), the stability protocol with current data, the spec sheet citing each TGO 93 attribute, and the supplier qualification trail.
3. Match the CoA line-by-line to the spec sheet. Every TGO 93 attribute must appear on the CoA with a measured value, the applicable limit, the method reference, and a pass result. Missing attributes go back to the lab.
4. Confirm cannabinoid content accuracy. The label claim and the assay result must fall within the TGO 93 tolerance for that product type. Document the calculation in the batch record. A lot that fails tolerance against the labelled product but passes spec for a different labelled product is a relabelling decision under change control, not a release decision.
5. Check the mycotoxin section. Aflatoxin B1 not more than 2 micrograms per kilogram. Total aflatoxins not more than 4 micrograms per kilogram. Ochratoxin A within TGO 93 limits. A pass on B1 alone is not a pass on the section.
6. Check heavy metals and inorganics. Arsenic, cadmium, lead, mercury all reported and all within applicable TGO 93 limits. Total ash not more than 20.0%. Foreign matter not more than 2.0%. ICP-MS is the standard method for the four metals.
7. Check microbiological attributes. Total aerobic microbial count, total combined yeasts and moulds, absence of Escherichia coli and Salmonella where applicable. Confirm the lab method matches the manufacturer’s validated method.
8. Sign and file. QAP signature on the batch release record with reference to every attribute checked. The signed record is the inspector’s primary evidence at the next TGA audit.

The traceability spine running underneath this checklist is seed-to-sale data. See ODC quarterly reporting cannabis Australia for the reporting-side detail.

How Does TGO 93 Compare with International Cannabis Standards?

TGO 93 is a national pharmaceutical-style quality standard, which sets it apart from the cannabis quality regimes in Canada and the United States. The numbers sometimes look similar, but the legal authority and the matrix-specific applicability never do. A QAP releasing for export, or assessing imported product for an Australian sponsor, must work to the destination instrument, not pattern-match across them.

Two practical implications for the multi-market QAP. First, an Australian product crossing into a Canadian or German file needs a re-test against the destination’s instrument. Numbers may match, methods and matrix-validation expectations often do not. Second, an import into Australia must arrive with TGO 93 conformance documentation, not the manufacturer’s home-market CoA. The Australian sponsor carries the TGO 93 evidentiary burden, and the inspector will ask for it line-by-line.

For the cross-jurisdictional view of testing limits in a different cluster, see our cannabis heavy metals testing limits reference on the Canadian regime.

Frequently Asked Questions

What is TGO 93 and when did it come into force?

TGO 93 is the legal name of the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017, the Australian quality standard for medicinal cannabis products. It was made on 21 March 2017 under the Therapeutic Goods Act 1989. The current compilation is F2022C01204, effective from 6 December 2022. The standard is administered by the TGA and is scheduled to sunset on 1 April 2027 under section 50 of the Legislation Act 2003, so a replacement instrument is expected before that date.

What are the aflatoxin limits in TGO 93 for cannabis?

TGO 93 sets the aflatoxin B1 limit at not more than 2 micrograms per kilogram and the total aflatoxins limit (sum of B1, B2, G1, G2) at not more than 4 micrograms per kilogram. Both limits must be met on every released batch. Aflatoxins are produced by Aspergillus moulds when plant material is dried too slowly, stored at too high a moisture content, or stored at too high a temperature. The mycotoxin section of a Certificate of Analysis must report both limits, not just B1.

Does TGO 93 require ICH Q2(R1) method validation?

Yes. Analytical methods used to demonstrate compliance with TGO 93 testing limits must be validated against ICH Q2(R1) principles: specificity, precision, accuracy, linearity, range, limit of detection (LOD), limit of quantitation (LOQ), and robustness. The validation pack typically sits in the manufacturer’s TGO 93 dossier and is reviewed by the QAP as part of supplier qualification, not at every batch. A method that lacks any of the eight validation parameters is a deficiency a TGA inspector will find quickly, and a single missing parameter can be enough to reject the analytical evidence supporting the release of the lot.

How are TGO 93 stability studies different from QC release testing?

Release testing is the per-batch CoA check against the TGO 93 testing limits at time of release. Stability studies are the long-running programme that supports the assigned expiry date, run on the actual marketed packaging under ICH Q1 conditions. Both are required. A TGO 93 dossier without an ongoing stability programme will not survive a TGA inspection because the expiry on every released bottle cannot be defended without stability data behind it. New product formulations or new packaging configurations need their own stability protocol before commercial release, not after.

Can a single CoA cover all TGO 93 attributes for a batch?

Yes in principle, no in practice. Most commercial labs do not run cannabinoid potency, microbial, mycotoxin, heavy metals, residual solvents, and pesticide residues on a single method, so the lot typically carries several CoAs. The QAP consolidates these into one batch release record that maps every TGO 93 attribute to the source CoA, method reference, measured value, applicable limit, and pass result. A manufacturer Certificate of Compliance is acceptable for the regulatory file provided the underlying lab CoAs remain in the batch file.

Does TGO 93 apply to clinical trial product?

Yes. Medicinal cannabis used in Australian clinical trials must meet TGO 93 unless an exemption is granted by the TGA. The investigator brochure and the manufacturer dossier need to demonstrate TGO 93 conformance for every clinical trial batch, and the QC release record sits in the trial master file. Variations from the standard are possible for early-phase trials but require a formal TGA pathway, not a desk decision by the sponsor.

Get the Full Australian Cannabis LP Compliance Checklist

The free PDF maps the TGO 93 testing limits to a four-checklist field guide covering ODC licensing under the Narcotic Drugs Act, PIC/S GMP v17, GACP cultivation, INCB traceability, and a 30-day priority-action plan a new QAP can run on day one.

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