The Therapeutic Goods Administration (TGA) has recently called out several medical cannabis companies for failing a product quality compliance audit.
All medical cannabis products supplied in Australia must meet Therapeutic Goods Order 93 (TGO93) requiring companies to test their products to ensure potency is within the permitted range.
The TGA audit – conducted by the National Measurement Institute (NMI) – showed some of these products were significantly weaker or stronger than they should have been. But ChemCentre, which conducts pre-market testing for Little Green Pharma, has rejected these findings and stands by their initial tests which showed the products in questions did, in fact, comply with TGO93.
But how can two equally accredited labs test the same batch of the same product and get different results? The answer, of course, is error.
When we think of errors, we usually think of big, blame-worthy mistakes. But in science, error does not always mean that someone has done something wrong.
Some degree of error is unavoidable, so much so that the entire scientific process is built around minimising – but not always eliminating – error. Even in the most highly accredited labs.
But it is important to distinguish between random errors (which are normal and can be managed) and systematic errors (which can cause serious trouble).
For example, when conducting an analytical test on biological material such as cannabis, it is standard practice, based on US Food and Drug Administration (FDA) or European Medicine Agency (EMA) guidelines, to limit error to within 15%. So, if the cannabis being tested actually contains 100mg CBD, you might measure anywhere between 85 and 115mg CBD. But some analytical tests for final medicinal products such as cannabis oils may be validated to a higher level of accuracy.