Much data and analysis floats around cannabis and its usefulness in treating a whole range of diseases. The US Food and Drug Administration (FDA) has only approved one prescription drug product containing cannabidiol (CBD) – an ingredient in cannabis – to treat two rare, severe forms of epilepsy.
As of June 2019, 33 states allow the use of cannabis for medical purposes. At the federal level, though, cannabis has been classified as a Schedule I substance under the Controlled Substances Act. Schedule I substances are those with a high potential for dependency and no accepted medical use. Therefore, the distribution of marijuana is still a federal offense.
For the cannabis industry, constantly evolving regulations intertwined with a ripe opportunity, plays out interestingly.
What are some of the challenges faced by the marijuana industry?
- In January this year, the Marijuana Regulatory Agency recalled marijuana products sold at thirteen different dispensaries in nine cities in the US, as three pounds of the products were found to have higher than permitted limits of Paclobutrazol, a plant growth inhibitor.
- In September last year, Health Canada suspended the license of an Ontario, Canada-based company for standard processing, medical sales, cannabis drugs and research due to non-compliance. As the Cannabis market grows for both medical and recreational use, so does the need for standardized quality control within the industry.
- Cannabis needs to be tested and analyzed at many levels, from the moisture content to testing the levels of terpenoids and CBD, testing the levels of pesticides and herbicides, microbiological screening and the presence of residual solvents in the final products.
- This mandates standardized procedures to ensure safe use, not just compliance. Needless to add, this is a nascent industry and standards are still evolving.
- It is important to understand that most cannabis companies depend on third-party labs for testing. Each lab follows its own testing methodologies and standards.
- Across the globe, as yet there is no agreement on standards for cannabis. Even amongst the states in the US, some permit, some do not.
- The number of states legalizing medicinal cannabis is on the rise, requiring a standard protocol like the ISO/IEC 17025:2017, meant for analytical laboratories.
What should the quality effort look like if you’re an emerging player in the Cannabis industry?
- From the harvesting stage to labeling and product release, marijuana needs standardized operations and procedures.
- Given the differing levels of awareness about permissible levels of cannabis, manufacturers need to be aware of the rules about cannabis in the markets they operate.
- Documentation, a document management system, version control of documents, risks and opportunities and the action taken, continuous improvement, corrective actions, internal audits, and management reviews are among the many things cannabis manufacturers need to know and manage on a day-to-day basis.
- Non-compliance can lead to product impounding, recall, fines, penalties such as license suspension or revocation, increased regulatory overview, slow approvals on products and exports, reduced revenue and damaged reputation. There are many examples in the media where a producer fails, and commensurate costs lead to the loss of careers when the stakes become high.
- Manual tracking of the varying standardization needs, as well as ongoing quality control, can be daunting.
- An end-to-end cloud-based EQMS solution that integrates with your ERP is a “must-have” at every stay of your product lifecycle.
How can an EQMS like ComplianceQuest help?
A product recall, especially in healthcare and pertaining to medical marijuana, can damage the reputation of the company and affect sales. Therefore, it is essential to ensure compliance and quality at all times.
ComplianceQuest can help in the following ways, especially in the Cannabis sector:
- By opting for an enterprise-wide control of quality, the company can make sure the entire organization across all key functions are aligned towards the same goals. This improves cross-functional collaboration as well as an exchange of knowledge regarding the pitfalls and strengths of the company’s systems and processes.
- The quantum of predictable quality improves and becomes more measurable with the setting down of parameters and metrics, and having a single EQMS that acts as the gold source of quality data.
- Dashboards and reports provide deep insights for course correction and visibility across functions. This reduces business risks and improves compliance and conformance.
- Document exchange and version control become easier. An audit trail is also easily available, and CQ can drive automation into your audit management process.
- We believe with the implementation of ComplianceQuest your overall cost related to managing quality and compliance processes comes down. The impact of investing in a cloud-based quality solution will deliver ROI in a very short time period.
- Implement a risk-based approach to manage non-conformances, deviations, CAPA and change management.
A cloud-based EQMS like ComplianceQuest offers 12 key solutions ideal for the cannabis industry. It is built with automation and customization as its fundamental principles, thereby empowering the quality leader to choose the modules applicable to his/her context and scale as the enterprise evolves.
The EQMS solution drives efficiency and productivity while reducing the complexity of operations.
Currently, ComplianceQuest serves customers in over 800 cities across the world in several sectors including Healthcare and Life Sciences, Aerospace and Defence, Automotive, Cannabis, Consumer Packaged Goods, General Manufacturing and Hi-Tech.
Request a demo and we can explain how ComplianceQuest has delivered digital transformation and automation for healthcare, biotech and Cannabis firms around the world. Please email us at [email protected] to schedule a demo.