Govern · ODC, TGA and Tasmanian Health

Licences & Compliance

Every licence, permit, quota and audit finding in one register, with the quantities checked against what the site has actually grown and manufactured. This is the layer that has to hold up when the Office of Drug Control walks in. And it is the reason the system itself is validated.

Licences held

2 renewals inside 180 days ODC · TGA · Tas Health

Open audit findings

next: 16 Sep 2026 ODC site inspection

Open deviations

1 critical SOP-QA-021

Documents migrated

85%

222 still in SharePoint controlled register

Licences

First Australian company to hold ODC cultivation, manufacture and research licences at the same time. Held by Fiona Ballard (Authorised Person) and Grant Petrusma (Security & Compliance Officer).

Licence	Authority	Number	Issued	Expires	Days left	Status
Medicinal Cannabis Cultivation & Production Licence	Office of Drug Control	CL-0087	1 Sep 2024	31 Aug 2027	399	Current
Medicinal Cannabis Manufacture Licence	Office of Drug Control	ML-0112	1 Sep 2024	31 Aug 2027	399	Current
Cannabis Research Licence	Office of Drug Control	RL-0041	15 Jun 2023	29 Sep 2026	63	Renewal due
Manufacturing Licence. AU-GMP (Step 1-5, sterile-free)	Therapeutic Goods Administration	MI-2024-LI-02318-1	12 Nov 2024	11 Nov 2027	471	Current
Schedule 8 Manufacture & Supply Authority	Tasmanian Department of Health. Pharmaceutical Services	S8-TAS-2024-118	2 Oct 2024	1 Oct 2026	65	Current
Medicinal Cannabis Export Licence	Office of Drug Control	EL-0029	10 Feb 2025	9 Feb 2028	561	Current

Permit quotas

Usage is counted straight off the crop batches, harvests and manufacturing runs. Not typed into a spreadsheet at the end of the month.

CP-2026-0184

Cultivation permit

66%

26,470 of 40,000 plants

Plants held at any one time · to 30 Jun 2027

CP-2026-0185

Production permit

27%

3.84 t of 14.00 t

Dried cannabis produced this permit period · to 30 Jun 2027

MP-2026-0091

Manufacture permit

27%

3.22 t of 12.00 t

Cannabis manufactured this permit period · to 30 Jun 2027

RP-2025-0033

Research permit

70%

418 of 600 plants

Plants held for research · to 29 Sep 2026

EP-2026-0219

Export permit. Germany

67%

26.6 kg of 40.0 kg

Consignment quantity · to 31 Oct 2026

EP-2026-0214

Export permit. United Kingdom

76%

26.7 kg of 35.0 kg

Consignment quantity · to 30 Sep 2026

Audits & inspections

AUD-26-014
ODC site inspection

Office of Drug Control · 16 Sep 2026

Scheduled

Annual cultivation & manufacture inspection. Security, seed-to-sale records, destruction logs.
AUD-26-011
TGA GMP re-certification

Therapeutic Goods Administration · 19 May 2026

2 open Open findings

4 of 6 findings closed. Open: cleaning-validation report for TRIM-01, and periodic review of SOP-QA-014.
AUD-26-008
Internal audit. Post-harvest

Tasmanian Botanics QA · 21 Apr 2026

Closed

Drying-room RH excursion logging tightened; all actions verified effective.
AUD-26-005
Customer GDP audit

Symbion Pty Ltd · 18 Mar 2026

Closed

Consignment stock reconciliation and recall-readiness both rated satisfactory.
AUD-26-002
Internal audit. Data integrity / CSV

Tasmanian Botanics QA · 10 Feb 2026

Closed

Computerised-system validation register established; audit-trail review cadence set to monthly.

Controlled document register

1,284 of 1,506 controlled documents migrated into the register. Batch records now issue from here.

1,284 of 1,506 documents under version control here

Ref	Title	Ver	Owner	Review due
SOP-QA-014	Batch release & Authorised Person sign-off	6.0	Fiona Ballard	11 Aug 2026
SOP-QA-021	Deviation, CAPA & change control	4.2	Fiona Ballard	20 Jan 2027
SOP-CU-006	Propagation & mother-stock management	3.1	Nathan Oakley	3 Nov 2026
SOP-PH-009	Drying, curing & moisture-content control	5.0	Danielle Frost	16 Feb 2027
SOP-PH-012	Bucking, trimming & grade separation	2.4	Marcus Whelan	30 Mar 2027
SOP-MF-003	AU-GMP primary packaging & N₂ flush	4.0	Yvette Mahood	8 Dec 2026
SOP-MF-018	X-ray irradiation & post-treatment handling	1.3	Yvette Mahood	27 Apr 2027
SPEC-FG-002	Finished dried flower. TGO 93 specification	3.0	Dr Ingrid Salter	12 Jan 2027
VAL-CSV-007	Computerised system validation. Operations platform	1.0	Fiona Ballard	1 Jun 2027
VAL-CLN-011	Cleaning validation. Bucking & Trim Hall (TRIM-01) · still in SharePoint	0.9 draft	Marcus Whelan	14 Aug 2026
SOP-SEC-001	Schedule 8 security, access control & destruction	7.1	Grant Petrusma	6 Oct 2026
POL-QMS-001	Quality manual & QMS scope	8.0	Fiona Ballard	25 May 2027

3 documents fall due for review within 90 days. VAL-CSV-007 is this platform's own computerised-system validation record: the evidence that the system you are looking at is fit for GMP use.