The Narcotic Drugs Amendment Act 2016 saw the rise of the medical cannabis industry in Australia, as it permitted the research, cultivation and production of medical cannabis and related products. Following this, the Therapeutic Goods Administration (TGA) had a new task on their hands, regulating the production/manufacturing of what was once a Schedule 9 (S9) drug.
As such, the TGA issued a new standard to specify the minimum quality requirements that unapproved medicinal cannabis products imported into and supplied/manufactured in Australia must adhere/conform to, this came be to be known as TGO 93 (Standard for Medicinal Cannabis).
TGO 93 stipulated that any company within Australia looking to import/export/manufacture Medicinal Cannabis products had to adhere to the standard and ensure that the active ingredients and cannabinoids present in the final product are strictly derived from the cannabis plant.
As TGO 93 involves recording, tracking and reporting on a range of macroscopic and microscopic examinations as well as chromatographic procedures, handling the data via a paper-based method becomes quite cumbersome and has no reportable audit trail.
This is essentially where we come in, QLIMS assists users with:
- Recording and tracking results from Cannabis Plant Tests and standard pharmacopoeial tests such as Alflatoxins, foreign matter, heavy metals, ochratoxin A, pesticide and Total ash.
- Recording, tracking and validating all the test methods required for assaying active ingredients and cannabinoids present in your cannabis samples
- QLIMS ensures that users employ only appropriately validated test methods to samples
- Individual testing and validation can be conducted for raw materials and final cannabinoid-based medical products
- Via QLIMS Specifications Module users can record a range of specifications for different raw materials and final products
- QLIMS Stability Module assists users with creating, recording and tracking shelf-life stability studies
- Adhere to microbiological standards by recording, tracking and specifying limits for a range of microbiological tests
- QLIMS reporting services can be used for generating COA’s and any other required compliance reports for both raw materials and final products
- A secure and reportable Audit Trail that tracks any changes made to tests and results while specifying who, what and when.