ComplianceQuest: A QHSE Solution that Addresses Quality Challenges Unique to the Cannabis Industry
With legalization across various parts of the states and countries, comes the need to ensure quality control, standardized testing, quality assurance and compliance to common industry and well-established regulatory standards. As with any other pharmaceutical drug, medicinal cannabis will need to undergo rigorous testing to ensure that it is both fit for human consumption and is delivered at the right potency to provide the medical and recreational outcomes that it is being taken for.
Even as growers, processors, packagers and distributors of cannabis look to big opportunities, they have to know what quality assurance measures will need to be taken. Despite the absence of a cannabis-specific regulation at this time, most will need to go further voluntarily to ensure the production and sale of the safest and most consistent cannabis quality.
Quality in cannabis manufacturing starts at the source – the growers and suppliers. Companies need to ensure that raw materials and active ingredients meet the set standards. This requires internal and periodic supplier audits and documentation to verify the purity of ingredients. Even after this, there has to be internal testing upon receipt of the materials, verifying that the COAs [certificates of analysis] match their claims. Companies need to produce robust SOPs and in-process quality checks in addition to process testing. Each step of the manufacturing process must be controlled through Good Manufacturing Practices (GMP) at the minimum.
A Good Quality System like ComplianceQuest
Even as the industry waits for more formalized regulatory standards, there are some traits that the quality system should have:
- Ensure an enterprise-wide state of control and predictable quality to ensure that regulatory and product safety requirements are fully met.
- Reduce the cost of compliance, while fully meeting industry expectations and regulatory agency, such as FDA, Health Canada requirements.
- Take a risk-based approach to manage nonconformances, deviations, CAPA and change management.
- Provide the top-down enforcement of SOPs, Quality System Regulations (QSR), ISO requirements and best practices.
- Sound training and monitoring of personnel.
- Improve profitability by reducing variability, eliminating waste, adhering to schedules and commitments and reducing cycle times.
- Provide a worry-free infrastructure with data and document access anywhere, anytime and from any device.
Need for Quality in Cannabis
Quality protects adult users from the health risks associated with adulterated or contaminated cannabis, and from the risks of consuming cannabis of unknown or unreliable potency. Despite passing laws to legalize cannabis for medical and recreational use, most states and countries have no established standards or regulations in place.
However, regulation is inevitable. In the meantime, the relatively rapid growth of the cannabis market has created competition such that vendors choose to self-regulate to high standards because products that do not meet quality standards will lose customers to other, better regulated competitors.
- Canada Cannabis Act
- Canada cGPP (Good Production Practices)
- US (only States-based – too many to list)
- ISO 14001
- ISO 18001/45001
- ISO 31000