Little Green Pharma has shifted its laboratory testing to the in-house lab of the Therapeutic Goods Administration (TGA) following the contentious publication of a TGA report identifying products which failed a potency audit.
The WA-based firm was one of four suppliers named in the audit whose products were found to have breached TGO93 requirements. The others were Althea, Spectrum Therapeutics and Bedrocan.
But the findings of the TGA, subsequent release of the report and public naming of the four suppliers appear to have exposed wider failings of the system and angered those accused of a breach.
It also reignited the thorny issue of imported medicinal cannabis amid concerns that inferior product is arriving in Australia without sufficient policing from the TGA. There is no suggestion the products named in the report failed any requirement other than the potency conditions.
ChemCentre, which conducts pre-market testing for LGP, was said to be incensed at having its analysis questioned. The facility insisted it “stands by all its results”.
Althea, LGP and Canopy Growth – the owner of Spectrum – were adamant their own test results were in line with tolerance levels. Bedrocan declined to comment until “ongoing discussions with the TGA are concluded”.
In total, the TGA said five products were in contravention of the regulations and failed to meet upper and lower limits of ingredients declared on the manufacturer’s TGO93 declaration.
Despite public backing from LGP chief executive Fleta Solomon, the discrepancy between ChemCentre’s results and that of the TGA audit has led LGP to switching its testing to NMI, the body which examined samples for the TGA.
“Until the relevant testing alignment has been completed and validated, the company will test its medicines at another Government-owned, NATA and TGA-licenced testing laboratory, itself engaged by the TGA to perform corroboration testing,” LGP said in a statement to the ASX. “This is to assure patients and prescribers that all Little Green Pharma medicines continue to be tested to the highest quality and clearly meet their label claims.”
LGP added it was “disappointed with the divergence” in test results and was working with ChemCentre and the TGA “to determine how the agency’s TGA-licenced testing methodology and the TGA’s own methodology have produced different results”.
Both ChemCentre and LGP are understood to have held late night board meetings when the results became known, with the WA-based lab convinced its processes and methodologies hold up to scrutiny.
It also emphasised its credentials in a statement to Cannabiz.
“ChemCentre is a National Association of Testing Authorities (NATA) accredited, Therapeutic Goods Administration (TGA) Good Manufacturing Practice certified laboratory,” the company said. “Our chemical analysis methodologies are developed and validated in accordance with the relevant international standards to ensure that they are fit-for-purpose, producing high-quality, accurate results. This includes analysis of final dose form medicinal cannabis products for legislative compliance based on Therapeutic Goods Order No. 93 (Standard for Medicinal Cannabis).
“All analyses carried out at ChemCentre undergo comprehensive, industry-leading quality assurance protocols. ChemCentre stands by all results that it produces.”
It is understood that making the audit public, and naming the suppliers involved, took many by surprise given that dialogue over the discrepancies was underway with the TGA.
“There is a feeling the TGA jumped the gun on the publication of this report, particularly with naming and shaming the products and suppliers involved,” one industry source said. “Given the reputational impact, it hasn’t gone down well with those involved.”
Among the questions being posed is what methodologies and standards were used by the TGA testing labs and whether the lack of unified procedures could have produced the variances.
ChemCentre said it encourages third party assessment of materials and processes as a means of “encouraging industry best practice and providing customers with surety”.
Yet the facility added: “It is critically important, however, that any such reporting is based on the most robust procedures, using appropriate technology and internationally accepted standards.
“As part of ChemCentre’s ongoing commitment to consistently producing accurate, defensible results, ChemCentre recently participated in a US-based International Medicinal Cannabis Hemp Oil proficiency trial. All ChemCentre results were within acceptable limits for all analytes determined, including CBD and THC.”
Furthermore, ChemCentre said it has reviewed its reports to clients “and found no issue”, adding it has initiated a sample exchange with multiple national and international agencies with results expected within six to eight weeks.
Both LGP and Althea have called for a uniformed approach to testing, while the Medicinal Cannabis Industry Australia (MCIA) said it will refer the issue to its standards sub-committee.
“I think the TGA simply need to provide their methodology for testing, especially if it differs from current industry norms,” Althea chief executive Josh Fegan said. “The TGA will improve their processes in time. We stand behind our products’ conformity 100%. All Althea stakeholders, including the TGA, know that we uphold gold standard regulatory and quality standards.”
The exact procedures used in the TGA sample tests is unclear, with the TGA saying “some” samples were tested by NMI to provide a third-party result.
Clarification was being sought at time of publication.
Responding to questions from Cannabiz, the TGA stressed NMI has NATA accreditation “to conduct analysis of controlled substances including cannabis specific cannabinoids”.
Asked what standards the TGA adopt, a spokesperson said: “TGA uses certified reference materials of CBD from NMI who hold accreditation to produce certified reference materials, and solutions for the other cannabinoids from Cerilliant. The TGA cannot comment on what reference materials other labs are using. “
Yet the lab results are part of a wider issue, according to MCIA chairman Peter Crock.
The “bigger question”, he said, is whether imported products are compliant with regulations before they reach Australia’s shores, and before they become finished products.
While not suggesting the specific products named in the report had breached regulations, he told Cannabiz it was clear medicines do reach Australia that do not meet GMP-equivalent requirements.
The MCIA is in on-going dialogue with the TGA to clamp down on potentially sub-standard product, Crock said.
“The bigger question is whether products are compliant with the requirements to start with because we are aware of products that have been imported that have not come out of a GMP facility and don’t have stability data to support their shelf-life claims,” he said.
“It’s not just the finished products that are an issue and we are formally pursuing this with the TGA.
“We know there are products that have come out of Canada and elsewhere that absolutely do not have the data to support claims that products have a 12 or 24-month shelf life.”
Crock called on the TGA to step up its policing in order to ensure the local industry can compete on a level playing field with imported products.