Quality and standardization

The quality of medicinal cannabis can vary greatly. This poses risks and uncertainties to patients and their prescribers. So, why is quality so important? 

Cannabis has been used in human clinical studies and found to be relatively safe for most people, compared to other medicines. However, some patients taking cannabis have had worsened symptom control and new side effects such as sleepiness, abnormal liver function and diarrhea. Absolute safety does not exist for any medicine. All medicines can pose a risk of side effects and possibly adverse effects (resulting in harms). In particular, large doses of THC and potent synthetic cannabinoids have been shown to pose a risk of harm (e.g. postural hypotension resulting in a fall, or a mild to severe psychotic event). 

The safest and most reliable products are of pharmaceutical-duality. These products meet good manufacturing practice (GMP) standards. GMP is the highest standard of medicine manufacture. GMP is an assurance of consistently high-quality products and production processes. For medicinal cannabis, GMP practices should start 

from the very first step, cultivation. right through the entire production process to the finished product. It is not just about the packaging of cannabis flower, or the production of an oil extract. Under GMP, each part of the medicine production and testing process must be clearly documented. Personnel, premises and materials must meet the highest standards. These processes provide patients and prescribers with the safest and most reliable products. 

A pharmaceutical-quality product could be, for example, cannabis flower for inhalation, a capsule for swallowing or a spray for the mouth. Each product type will require a slightly different set of tests for quality. These tests are often published. The pharmacopoeia monographs, for example, are the most reliable published methods for the analysis of medicines. These monographs explain the standards for potency, quality and so on. Medicinal cannabis products are required to be independently tested by specialized laboratories. The tests laboratories undertake often include: 

The identification of cannabis – Medicinal cannabis products typically must be derived only from the cannabis plant. An important first step is to test the plant material to confirm it is actually cannabis, and not an adulterant or substitute. 

The identification of active ingredients – There are numerous components of the cannabis plant. This test typically requires identifying THC and CBD, and often the terpene content. 

The absence/presence of microorganisms – During cultivation, the cannabis plant can host harmful microorganisms like fungi and bacteria which can end up in the finished product. This may require decontamination treatment by gamma irradiation to eliminate microorganisms such as Staphylococcus Aureus and Escherichia Coli. The process must not affect the quality of the finished product. 

The absence/presence of pesticides – Many different types of pesticides can be used in cannabis cultivation, but none are approved for use in cannabis. This test ensures the finished product does not contain pesticides which are very harmful to patients’ health. 

The absence/presence 0f heavy metals – The cannabis plant can quickly take up heavy metal referred to as heavy metal bio—accumulation, Every batch must be checked for the presence of heavy metals such as arsenic, cadmium, lead and mercury. 

The absence/presence of foreign matter – It is essential that the final plant material (and the finished product dose form) is free from impurities such as dust, dirt and other contaminations. 

The total water content — For cannabis flower which is intended to be inhaled by vaporization, the final water content is important. The right amount of moisture (water content) in dried cannabis flower assures an easy inhalation process during vaporization.