Australia’s Medicinal Cannabis GMP Rules and Where CSQ Certification Fits

Yes, for manufacturing. Carrying out a step in manufacturing therapeutic goods, including processing, packaging, labelling, storage, testing and release for supply, requires a TGA manufacturing licence unless an exemption applies (Therapeutic Goods Act 1989 ss 3, 35). Every licence requires compliance with the Manufacturing Principles, which adopt the PIC/S Guide to GMP (PE 009-17), and products must meet TGO 93. Australia does not require a private GMP certificate.

Two federal regulators. The Office of Drug Control administers the Narcotic Drugs Act 1967 and licenses cultivation, production, manufacture, import and export. The TGA regulates quality under the Therapeutic Goods Act 1989: manufacturing licences, GMP, the TGO 93 product standard and the access schemes. A licence from one does not replace a licence from the other. States and territories give medicines scheduling legal effect and, depending on the product, may require their own prescribing approval.

Not always. Plant material and crude oils used only as starting materials by a licensed manufacturer are exempt (Therapeutic Goods Regulations 1990 Schedule 7 item 2). TGA says this lets cultivation sites grow, cut and dry plant material, or perform the first crude extraction, without a GMP approval when the material goes on to a GMP-licensed site. The exemption does not cover steps such as packing finished product, refining beyond the first crude extract, decontamination, testing for release or release for supply. Growers still need an ODC licence and permits, and TGA expects GMP principles throughout.

No. Only TGA can license an Australian manufacturer. For steps carried out overseas, TGO 93 accepts only GMP certificates issued by listed government authorities, or written confirmation from TGA (s 13(3)). A CSQ certificate, like any private certificate, is not that evidence, is not TGA approval, and does not replace an ODC licence or permit.

A scope expansion CSQ is launching for Level 3 certified operations that handle cannabis as medicinal cannabinoid products. It incorporates US 21 CFR Parts 210 and 211 and EU GMP (EudraLex Volume 4, Parts I and II), with ICH, Ph. Eur., USP, cGACP and other recognised standards, and it covers starting materials, APIs, intermediates and finished products. CSQ describes it as a private third-party conformity assessment, not a regulatory GMP certificate or authorisation.

Australian manufacturing licences apply the PIC/S Guide to GMP (PE 009-17). For steps carried out overseas, TGO 93 lists the GMP codes it accepts, including the PIC/S Guide, the EU GMP rules and US 21 CFR Part 211; the Addendum is built on EU GMP and 21 CFR 210/211. That shared foundation does not make a CSQ certificate acceptable GMP evidence under TGO 93, which requires evidence from a government authority or TGA.

An ODC-licensed grower or producer uses CSQ Cultivation v2.0.0 (with CSQ Extraction v2.0.0 for a first crude extract); a manufacturer uses CSQ Extraction or Manufacturing v2.0.0; storage and distribution sites fit CSQ Warehousing & Distribution v1.0.0. To add the Pharma-GMP Addendum, the certification must be at Level 3. Testing laboratories follow ISO/IEC 17025; CSQ does not certify labs. Kiwa ASI can combine scopes into one coordinated audit.

Level 3 covers CSQ Modules 1–5. After an offsite documentation evaluation, the initial onsite audit is unannounced, 30–60 days later, with a minimum of 2 days onsite. Audits are scored out of 100: 80–100 earns a certificate with annual recertification, 70–79 earns a certificate plus a 6-month surveillance audit, and below 70 means no certificate. A single Critical finding fails the audit. Certificates are valid for 1 year plus 45 days.

CSQ is a private, voluntary certification program for cannabis and hemp operations. Audits are carried out and certificates issued by certification bodies that CSQ licenses and that must be accredited to ISO/IEC 17065. Today CSQ lists one licensed certification body: Kiwa ASI (ASI Food Safety, LLC), accredited by ANAB to ISO/IEC 17065. Audits for Australian operations are coordinated with Kiwa’s Australian team, Compass Assurance Services, Kiwa’s certification office in Queensland.

CSQ is owned by ASI Global Standards, LLC. CSQ discloses that its parent company, ASI Holdings, also owns ASI Food Safety, LLC, Kiwa ASI’s certification body, and it publishes an impartiality statement about that relationship.

CSQ certifies cannabis and hemp operations. In Australia, industrial hemp (no more than 1% THC) is licensed for non-medicinal uses such as fibre and seed by state agencies, for example Biosecurity Queensland, Agriculture Victoria and PIRSA in South Australia. Growing or making cannabis for medicinal purposes, including low-THC material, needs ODC licences and permits.

Because Australia’s GMP licensing starts at manufacture, while the steps before it (growing, cutting, drying and first crude extraction) can run without a TGA licence. CSQ gives those upstream sites an independent, annual audit, and the Pharma-GMP Addendum puts drying and curing under cGMP. For manufacturers and sponsors, CSQ certificates on suppliers add independent verification to supplier qualification. TGO 93 has no pre-market check: TGA verifies compliance through random and targeted audits and testing. CSQ does not certify TGO 93 compliance, but its annual audits give buyers independent evidence of the quality system behind a product.