As South Africa's cannabis sector grows, so do the questions around compliance, safety, and quality. Reference standards in South Africa are often sourced from United States Pharmacopeia (USP). These standards are critical for quality control. "They are used to verify both the identity and concentration of active ingredients in finished products and check for impurities that can accumulate from soil, air, or poor post-harvest handling," explains Marthinus Visser Steyn from Stargate Scientific, a company supplying analytical labs and pharma companies with high-grade consumable and reference standards. "Our main goal is to bridge the awareness gap between regulation and real-world implementation."
"We're not manufacturers or cultivators," says he. "We're a trader in laboratory consumables and pharmaceutical instrumentation. And most importantly, we import chemical reference standards that allow manufacturers and testing labs to ensure their products meet international specs."
The gold standard
In South Africa, the regulatory benchmark is based on ICH guidelines, the International Council for Harmonization. "SAHPRA uses these as the basis for enforcing GMP and ensuring public health protection. When it comes to medical cannabis, the bar is set by FDA and EU-GMP standards." The problem? Not everyone in the industry knows this – or knows what to do with it, according to Marthinus.
A standards gap
"There's a serious lack of awareness in the cannabis industry around how standards should be used," says Marthinus. "We saw it firsthand during our recent industry engagements – people don't even know what standards are available to them, let alone how to apply them in cultivation, processing, or formulation."
One result is inconsistency. While some producers follow rigorous protocols and go through contract labs to verify their product quality, others skip these steps entirely. "There are plenty of products on shelves here that don't meet proper quality standards," he adds. "There's no typical recall process, because the groundwork for consistent enforcement just isn't there."
According to Marthinus, the root issue is a misalignment between regulators like SAHPRA and cannabis operators. "Producers invest in land, infrastructure, processing facilities – only to realize too late that they don't have the right license for what they want to do. They might get a Section 22 license, which allows them to cultivate and export, but forget about Section 21, which is needed to register a finished medical product for local sale. The pieces don't line up."
Labs, licenses, and learning curves
South Africa currently hosts 5 to 6 contract labs – possibly more – each offering specialized testing capabilities. Some focus on biological or herbal products, others on small-molecule medicines. The labs are competitive, which creates a kind of peer-review system: if one lab delivers questionable results, there's a good chance another will catch it. "No lab wants to be caught cutting corners, because they know someone else is likely running the same batch," says Marthinus.
This system creates a level of quality assurance, but it only works if producers know how to use it. "There's this misconception that if you follow standards, you have to change your product to fit in some rigid box," he adds. "But standards aren't there to restrict you – they're there to protect both the patient and the manufacturer."
That includes everything from how ingredients are stored (temperature, humidity, light exposure) to the exact method of analysis used in quality control. Stargate Scientific's job, as they see it, is to help companies navigate all of that – to understand what they're required to do and where to source the tools to do it.
Safety isn't just a checklist
"The standards we promote aren't arbitrary," Marthinus says. "They're about protecting the end user, yes – but also protecting the manufacturer from liability. If someone gets harmed by a product, the entire industry suffers. Proper standards reduce that risk."
As a supplier of USP and other pharmacopeial standards, Marthinus and Stargate Scientific see themselves as part of the safety net. "We're here to make it easier for the industry to comply with what's already required. Awareness is the first step. Without it, companies either overinvest in infrastructure they don't need or fail to prepare for the quality control they absolutely do need."
For South Africa's cannabis market to mature, that awareness has to improve – not just among producers, but across the whole supply chain. As Marthinus puts it, "If the right standards are in place and applied correctly, everyone benefits – growers, labs, regulators, and patients. It's not a burden. It's the baseline."
For more information:
Stargate Scientific
+27 11 675 7433
[email protected]
stargatescientific.co.za