- Cultivation (GACP Site)
Cannabis cultivation under TGA-recognised GACP standard. Australian domestic cultivators hold ODC cultivation licences. Overseas cultivators require GACP certification for Australian import.
- GACP Controls
Cultivation, harvest, and post-harvest processing under GACP. TGA accepts EU GACP and WHO GACP for imported products.
- Irrigation, fertilisation and pesticide logs
- EU MRL pesticide basis for imported product
- Harvest moisture target ≤10% (dried flower)
- Environmental monitoring records
- Manufacturing IPC
GMP-compliant manufacturing with in-process controls. TGA GMP is PIC/S-aligned — identical standard to EU-GMP in practice.
- Weight uniformity checks
- HPLC cannabinoid content at IPC stages
- Cleanroom environmental monitoring
- Line clearance records per batch
- Finished Product Testing
Full release panel per TGA and Australian Pharmacopoeia / British Pharmacopoeia standards.
- Identity and assay: THC, CBD, cannabinoid profile (HPLC)
- Microbiological: TAMC, TYMC, E. coli, Salmonella, Staph aureus
- Pesticide residues (APVMA MRL basis)
- Heavy metals: Pb, Cd, Hg, As (TGO 101)
- Moisture content (dried flower)
- Residual solvents (extracts, ICH Q3C)
- All specs pass?
All results must comply with TGA-approved specifications and pharmacopoeial limits.
- OOS Investigation
TGA-compliant OOS investigation procedure. Root cause analysis, retesting protocol per TGA guidance on OOS results.
- Phase 1: laboratory investigation
- Phase 2: manufacturing investigation if Phase 1 inconclusive
- Batch disposition: release, rework, or reject
- QP / Nominated Person Review
Qualified Person (overseas sites) or TGA-nominated person reviews full batch record, all test results, and certifies compliance before Australian release.
- Full batch manufacturing record reviewed
- All IPC results within approved limits
- All deviations closed and impact-assessed
- GACP and GMP certificates current
- Batch Released ✓
Batch certified for Australian supply. Available for distribution via TGA-licensed wholesale channels to pharmacies and hospitals against Schedule 8 prescriptions.