In an era where cannabis emerges from the shadows into legitimate industrial, recreational, and medical realms, the importance of stringent quality control cannot be overstated. This flourishing industry demands meticulous oversight to ensure safety, efficacy, and consumer confidence. From the scrupulous cultivation of medical-grade strains to the precision of extraction processes for recreational products, every step must adhere to rigorous standards created to monitor and evaluate various aspects of the manufacturing process to detect and address deviations or defects that could affect the final result.
The concept of quality became a well-established topic and the concept of Quality Assurance (QA) and Quality Enhancement (QE) are widely used in higher education institutions. It is possible to consider QA as a “diagnostic” process, while QE comes, in this case, as a subsequent “treatment” process to develop the limitations that QA discovered.
This simply means that the purpose of QA is to “enhance” the quality. Additionally, it is noticeable in recent years that there has been a greater emphasis on QE rather than QA. [1]
What Specifically is Quality Control?
The Quality Management Systems (QMS) comprehend the framework, policies, processes, and procedures put in place to ensure consistent product quality. ISO 9001, for example, is a widely adopted standard for QMS. Total Quality Management (TQM) is a management approach that focuses on continuous improvement of processes, products, and services to meet or exceed customer expectations and this kind of like the ones according to ISO 9001 can help to maintain a long trusting relationship with consumers.
Some of the most important topics in quality control are:
- Statistical Process Control that involves the use of statistical methods to monitor and control manufacturing processes. Techniques such as control charts help identify variations and maintain process stability.
- The Root Cause Analysis is a systematic method for identifying underlying causes of problems or defects. It helps prevent recurrence by addressing the root causes rather than just symptoms.
- Quality Control Tools, such as Pareto analysis, scatter plots, and histograms are used for analyzing data and identifying areas for improvement.
- Supplier Quality Management is vital for upholding product quality standards, entailing thorough evaluation, audits, and ongoing performance monitoring of incoming materials and components.
- Process Capability Analysis, that is, evaluating the ability of a process to meet specific requirements is essential to ensure consistency and predictability of the output.
- Industries should follow policies that emphasize a culture of continuous improvement and encourage continuous efforts to improve quality, efficiency, and customer satisfaction.
Quality characteristics fall into two broad classes: variables and attributes. Characteristics that are measurable on a numerical scale are called variables.
Prior to defining an attribute, we should define a nonconformity and a nonconforming unit:
- A nonconformity is a quality characteristic that does not meet its stipulated specifications. Let’s say that the specification on the fill volume of packages is 30.0±0.3 grams (g). If we have a bottle containing 29.5 g, its fill volume is a nonconformity.
- A nonconforming unit has one or more nonconformities such that the unit is unable to meet the intended standards and is unable to function as required. An example of a nonconforming unit is an external packaging whose internal diameter and length do not meet specifications, thus rendering the unit dysfunctional
A quality characteristic is said to be an attribute if it is classified as either conforming or nonconforming to a stipulated specification. [2]
The Quality of Conformance implies that a manufactured product or a service rendered must meet the standards selected in the design phase. The Quality of Performance is concerned with how well a product or service performs when put to use. It measures the degree to which the product or service satisfies the customer. [2]
Reliability refers to a product’s ability to function effectively for a certain period under certain conditions. Reliability is guaranteed by the quality of the design. [2] For example, in the cannabis industry this might be called the shelf life of products. Kept in perfect environmental conditions relating to humidity, temperature and sunlight, the product will be used “best before end” of a period that can satisfy most of the customer’s needs.
QC in the Cannabis Industry
First, you need to develop a sampling plan to outline how and when to collect samples during the cannabis production stages: cultivation, processing, and packaging.
Consider sample size, frequency, locations, and techniques. Collect samples from different cannabis products such as flowers, extracts, and edibles, following established protocols for accuracy.
Meticulously document results, methods, and deviations to facilitate monitoring and regulatory compliance. Analyze data over time to spot trends, after identifying sources of contamination, improve production and control measures. Implement corrective actions such as sanitization, process adjustments, or equipment maintenance as needed. Regularly verify and validate procedures through proficiency testing, method validation and internal audits to ensure reliability and compliance.
Cannabis has been used medicinally throughout history, but its recent legal prohibition, its biochemical complexity and variability, quality control issues, previous shortage of adequately powered randomized controlled trials, and lack of relevant education have conspired to leave doctors in the dark about how to counsel patients pursuing such treatment. With the advent of cannabis-based pharmaceutical drugs like Sativex and Epidiolex, and the liberalization of access in some nations, this ignorance about cannabis pharmacology and therapies has become unsustainable. [3]
Some scholars in 2018 presented practical considerations on attempting to present concise data on cannabis pharmacology related to tetrahydrocannabinol (THC), cannabidiol (CBD), and other cannabinoids, administration methods (smoking, vaping, oral), and dosing recommendations. The initial dose should start at modest levels and titration of any cannabis preparation should be done slowly over a period of up to two weeks. The same researchers offered suggestions on cannabis-drug interactions, patient monitoring, and implementation of standards of care, while special cases are addressed for cannabis therapies for the treatment of epilepsy, for palliative and primary therapy for cancer, in chronic pain, use in the elderly, Parkinson’s disease, pediatrics, with concomitant use of opioids and above all to potential side effects in relation to driving and dangerous activities. [3]
This type of study will allow us to structure real therapies based on the quantity of active ingredients contained in the cannabis-derived product. Ensuring the quality of a dosage reliably uniform with that prescribed by the doctor.
Chemical and Physical QC
Involving a series of chemical-physical analysis means guaranteeing the safety, effectiveness, and quality of the product. Potency tests, conducted via methods such as HPLC or GC-MS, evaluate the consistency of cannabinoid and terpene levels. Residual solvent analysis, using techniques such as GC-FID or HS-GC, ensures that extracts are free of harmful solvent residues. Heavy metal analysis, using ICP-MS or AAS, detects and quantifies metal contaminants. Pesticide residue analysis, using LC-MS/MS or GC-MS/MS, helps verify that pesticide residues meet regulatory limits. Determination of moisture content and measurement of water activity evaluate the stability of the product. Appearance and color analysis maintain product consistency while density and viscosity measurements provide information on the consistency of the product.
Quality control in cannabis-based products is crucial in the growing legal market, but it’s closely tied to issues in the illegal one: consumers aren’t adequately protected due to the absence of contaminating substances that would otherwise be intercepted through analysis, resulting in batches that are non-compliant for the global market.
The available data in literature is mainly based on legal and medicinal cannabis, but on a global scale, the legal cannabis consumption is still much lower than the illegal consumption. In fact, in the USA, about 55 million people consume cannabis on a regular basis while only about 2 million people consume legal medicinal cannabis. [4]
Researchers in 2021 investigated the presence of aflatoxins (AF) and ochratoxin-A (OTA) in samples of illegal cannabis. The samples analyzed in this study were herbs, flowers and resins confiscated by the Luxembourgish police in 2016 and 2017. The sample preparation protocols were formulated according to the suggestions provided by the supplier of the immunoaffinity columns utilized for the identification of target contaminating molecules. The method validation was done on blank cannabis material containing AF and OTA under the limit of detection (LOD). No AF contamination (LOD = 0.04 μg/kg) was detected in any of the samples analysed. OTA however was detected in about one-third of the samples with an average concentration of 4.30 μg/kg (range from 1.02 to 16.21 μg/kg). No significant difference was observed between resin and herbal samples. [4]
This is an example for everyone, but it’s clear how crucial QC is, and legalization goes hand in hand with it, because quality assurance ensures long-term safety for use.
Microbiological QC
To carry out quality control, industry workers collect samples for microbiological analysis using standardized procedures, employing techniques such as homogenization or dilution for uniform microbial distribution.
They perform microbiological testing, including aerobic microbial enumeration, yeast and mold enumeration, and pathogen detection via molecular or culture-based methods, and then incubate the samples under appropriate conditions to promote microbial growth. Microbiological analysis, including aerobic/anaerobic/coliform counts and pathogen detection, identifies microbial contamination.
Interpreting results against established standards helps determine compliance or the need for corrective action.
According to Web of Science data from 2019, only a tiny fraction of published articles—less than 1%—focus on Cannabis microbiomes, including fungi and bacteria. Additionally, pathogens, mycotoxins, and organisms causing product spoilage are just 0.5% of the total papers. Phytopathology and computational disciplines were also underrepresented. Rising demand for Cannabis may increase pathogen and toxin risks, especially in greenhouse conditions. Contaminants like molds and toxins pose health risks, especially to vulnerable groups. Quality research is crucial for ensuring safe Cannabis production and healthcare use. [5]
Visual QC
Packaging integrity testing ensures product freshness and safety. These controls allow producers to comply with regulations and provide consumers with safe, high-quality cannabis products.
By tracing the products used for the packaging it is possible to obtain a lot of information on the conformity of the final product, the expiry date must be evaluated by establishing a shelf life standard, perfectly visible and reported on each package. Obviously, the packaging should also inform about the risks, with adequate indications, on recreational and food products derived from cannabis.
A case study of 2021 on the effectiveness of health warnings and branding on packaging investigates the perception of cannabis products among youth and young adults (18-30 years old). The findings demonstrate that brand images on cannabis packaging can promote lifestyle associations and increase the attractiveness of cannabis products among young people. Plain/standardized packages carrying health warning labels (HWL) were perceived as less attractive than branded or non-HWL packages. Lifestyle associations can be communicated through brand imagery on cannabis packaging. [6]
The policy should protect consumers from counterfeit cannabis products from the illicit market. Research and literature regarding these topics should be greatly expanded, allowing a high exchange of information between production companies and control bodies with the sole objective of ensuring continuous sustainable development of the legal cannabis market.
References:
- Elassy, N., “The concepts of quality, quality assurance and quality enhancement”, Quality Assurance in Education, Vol. 23 No. 3, pp. 250-261, 2015.
- Mitra, Amitava. Fundamentals of quality control and improvement. John Wiley & Sons, 2016.
- MacCallum, Caroline A. et al. “Practical considerations in medical cannabis administration and dosing” European Journal of Internal Medicine, 2018.
- Buchicchio L, Asselborn L, Schneider S, van Nieuwenhuyse A, Moris G, Schummer C. Investigation of aflatoxin and ochratoxin A contamination of seized cannabis and cannabis resin samples. Mycotoxin Res. 2022.
- Vujanovic, V.; Korber, D.R.; Vujanovic, S.; Vujanovic, J.; Jabaji, S. Scientific Prospects for Cannabis-Microbiome Research to Ensure Quality and Safety of Products. Microorganisms 2020.
- Leos-Toro C, Fong GT, Hammond D. The efficacy of health warnings and package branding on perceptions of cannabis products among youth and young adults. Drug Alcohol Rev. May 2021.
