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Australia: TGA CBD / Medical Cannabis Audit Stirs Up Hornets Nest

The Cannabiz story published late last week about failed testing of imported medical cannabis products has certainly got tongues wagging and about time too.

Good, at last, to see these discussions in the open.

Anybody conversant with the US & Canadian markets will feel like it is groundhog day when reading the highlights below.

We concur that it is about time the private testing companies and the TGA work on the same standards.

But, more importantly, it is imperative that dialogue is both public and transparent and what seems obvious from this Cannabiz article is that ChemCentre are chucking a bit of a wobbly about the fact that this conversation is now in the public eye.

At CLR we don’t actually believe that the blame lies with either the TGA or ChemCentre,  per se, rather the Australian modus operandi of don’t tell the people unless they force it out of us is at fault !

If we’ve learnt anything from reporting the North American experience over the past 6 years , it is, that, transparency and communication are the key to getting through these issues so that there’s a testing regime that can be relied upon.

We haven’t even started on track n trace  & seed to sale here in Australia another area where all the same mistakes are bound to be made unless public access & transparency is incorporated from the get go.

Highlights include

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 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.
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”.
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
“All analyses carried out at ChemCentre undergo comprehensive, industry-leading quality assurance protocols. ChemCentre stands by all results that it produces.”
“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.

Read the full article at

Tension grows over TGA audit as LGP lab ‘stands by all results’

Who are ChemCentre ?

They say on the site

Medicinal Cannabis and Industrial Hemp

ChemCentre has become one of the few laboratories in Australia to be granted a Therapeutic Goods Administration licence and Good Manufacturing Practice (GMP) certification.

The licence and certification mean ChemCentre will now be able to offer analysis of final dose form medicinal cannabis products for legislative compliance based on Therapeutic Goods Order No. 93 (Standard for Medicinal Cannabis) This testing includes determination of an extensive cannabinoid profile as well as the analysis of terpenes, mycotoxins, heavy metals, pesticides, foreign matter and residual solvents, with a significant number of these analyses also being NATA accredited.

This capability can be accessed by manufacturers and distributors seeking to enter new and emerging international markets where this level of certification is required.

The accreditation also facilitates involvement in other analyses for the food, pharmaceutical and supplements industries and demonstrates to our clients our continued commitment to delivering a high-quality service.

Our highly trained scientific staff are also readily available to provide consultancy services that can assist with queries regarding product development, formulation and analysis.

Our scientists are experts at solving those difficult chemical problems, if you have questions regarding product analysis or development we are here to help.


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