On the 21st March 2017, the Therapeutic Goods Order No. 93 (Standard for Medicinal Cannabis) was enacted. This order sets the quality requirements which medicinal cannabis products have to comply with.

Companies looking to import, export, or supply therapeutic goods are obligated under the Therapeutic Goods Act 1989 to comply with these standards.

Types of materials which need to conform to the standard:

Medicinal cannabis material imported, exported or supplied in Australia

Cannabis plants used in the manufacture of medicinal cannabis products

Other ingredients used in manufacturing e.g. excipients

Steps and procedures in the manufacture of medicinal cannabis products

TGO 93 acceptance criteria

Aflatoxins

2 µg/kg of aflatoxin B1; 4 µg/kg for the sum of aflatoxins B1, B2, G1, G2

Pesticides

European Pharmacopoeia 2.8.13. Pesticide residues limits

Heavy Metals

3.0 ppm of arsenic,  0.5 ppm of cadmium, 5.0 ppm of lead, 0.5 ppm of mercury

Ochratoxin A

20 µg/kg

Foreign Matter

Not more than 2% w/w

Total Ash

Not more tan 20.0%

Active ingredient

The active ingredient is defined as the therapeutically active ingredient which is responsible for the physiological or pharmacological action in the medicine. According to TGO 93,

  • any tetrahydrocannabinol (including any corresponding acid) greater than or equal to 1.0% w/w or w/v of the product
  • any other cannabinoids (including any corresponding acid) greater than or equal to 2.0% w/w or w/v of the product

will be considered to be an active ingredient. The corresponding acids are the decarboxylated forms of the cannabinoids. The contents of any material are expressed as the sum of both the cannabinoid and corresponding acid. The stated content is the quantity or proportion to the active ingredient which is stated on the label of the medicinal cannabis product. 

Method Validation

In order to confirm that an assay or method provides consistent, reliable and accurate data; validations have to be performed to judge the quality, reliability and consistency of analytical results. 

A validation has to cover various parameters such as Specificity, Selectivity, Precision, Accuracy, Linearity, Range, Limit of detection, Limit of quantitation, Robustness and Ruggedness.

For medicinal cannabis products, TGA require validations to be performed on all assay methods as per the ICH Harmonised Tripartite Guideline Validation of Analytical Procedures: Text and Methodology Q2 (R1). 

Accepted chromatographic procedures

High Performance Liquid Chromatography (HPLC)

An analytical chemistry technique which pumps the sample in a liquid mobile phase through a column packed with solid adsorbent material.

gas chromatography

An analytical chemistry technique which pumps the sample in a gas mobile phase (usually an inert gas) through a column packed with a microscopic layer of liquid or polymer.

thin-layer chromatography

An analytical chemistry technique in which the sample is carried in a liquid mobile phase on a thin layer of adsorbent material – usually a sheet of glass, plastic, or aluminium foil.

References

  1. Therapeutic Goods Order No. 93 (Standard for Medicinal Cannabis), 2017, Australian Government
  2. Pharmaceutical Preparations (2619) European Pharmacopoeia (9th edition), 2017, EDQM Council of Europe
  3. ICH Harmonised Tripartite Guideline Validation of Analytical Procedures: Text and Methodology Q2 (R1).