The Centre for Medicinal Cannabis (CMC) has outlined their plans to undertake a comprehensive review of analytical testing for the cannabis industry.
Recent market research commissioned by CMC demonstrated that CBD and related cannabinoids are gaining rapid expansion in products aimed at wellness and medicinal markets.
However, despite there being a growing body of analytical methods for the testing of cannabinoids and other compounds in these products, few have been validated using internationally accredited guidelines. Moreover, standardised methods have yet to be developed for application at various stages of manufacturing as well as for different levels of processing and refinement.
The result is that products can show different results depending on who does the testing due to different labs utilising different testing methodologies. This can lead to companies shopping around for favourable testing results that do not truly reflect what the products contain.
Analytical testing
There is a need for a set of validation parameters for establishing robust standardised analytical methods for measuring cannabinoid content within different cannabis derived CBD-based products.
To achieve this, CMC is coordinating a collaborative research initiative made up of industry stakeholders (CMC members) to address potential barriers to analytical method standardisation in the CBD-space. This review is being led by Dr Parveen Bhatarah, recently appointed CMC’s Regulatory and Compliance Lead.
The objective is to have either standardisation method agreement or show method equivalence in testing various product ranges by different analytical labs when testing for the following:
- Analytical testing to confirm cannabinoid contents;
- Genotoxicity;
- Carcinogenicity;
- Heavy metals;
- Residual solvent;
- Pyrrolizidine Alkaloids;
- Microbial;
- Mycotoxins;
- Pesticides; and
- Terpenes.
This will ensure that all the methods generated will be validated to the highest analytical standards such as the International Conference on Harmonisation. Such harmonisation is critical for this rapidly expanding new industry to adhere to national, European and International standards criteria, such as EFSA’s Novel Foods applications.
CMC will be setting up an approach by designing the protocols for Analytical Quality by Design (AQbD) to overcome these CBD analytical testing challenges. CMC held a testing workshop on 30 of September with industry stakeholders and a follow up workshop date will be confirmed soon.
Dr Parveen Bhatarah, CMC Regulatory and Compliance Lead said: “Any company in this space will no doubt have faced a number of problems when analysing cannabis products. If there is no standardisation, there is no recourse for companies or customers to question test results.
“The lack of standardisation is hurting the industry’s ability to present cogent arguments on key matters such as defining ‘zero-detectable THC’; the CMC’s efforts in addressing this broad-ranging subject is significant for the industry to move forward.”
Dr Andy Yates, CMC Pharmacy Lead, said: “For the sector to continue growing, the conversation around the standardisation and confidence in testing methods is key. Without this, issues on product safety and quality will plague the industry. We are delighted our members and the wider industry are working together towards a solution.”
Centre for Medicinal Cannabis
The Centre for Medicinal Cannabis (CMC) is the UK’s first and only industry membership body for stakeholders operating in Cannabis Based Medicinal Products (CBMPs) and cannabidiol (CBD) wellness markets. We have a unique capability to engage intelligently and strategically with all influential political and public policy stakeholders, as well as relevant regulatory bodies, drawing on the experience from our global membership base. More information about The CMC can be found at www.thecmcuk.org .
