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CB-1 receptor – A cannabinoid receptor located primarily in the central and peripheral nervous system. The cannabinoid THC has been shown to possess a very high binding affinity with CB1 receptors. That is why consumption of cannabis strains and plants containing a high amount of THC result in a relatively potent effect, giving patients significant relief from pain, nausea, or depression.
CB-2 receptor – A cannabinoid receptor located predominantly in the immune system but also in the brain, peripheral nervous system, and gastrointestinal tract. CBD has affinity to CB-2 receptors
Quality system establishment and procedures writing, analysis methods procedures writing, validation for analysis equipment, software and analysis methods, GLP and/or ISO 17025 and data integrity.
As new regulatory requirements are being published and adopted worldwide, there should be a Quality Control laboratories in order to assure that the cannabis plants and cannabis products meet in-process and release specifications. The cannabis plants that are safe and high quality are becoming a “must” and cannabis developed products are being analyzed and tested. Currently, not all the cannabis growers and manufacturers are able to build these quality controls and analysis capabilities in-house.
Research and development efforts in the cannabis industry should end up in pharma-grade products that will be used by people and pets. Therefore, it needs to be standardized and controlled, following GLP requirements.
In Israel, based on Bio-Med’s and Agri-Med’s vast experience and innovation, medical Cannabis has been researched for many years. Along with Prof. Mechulam’s scientific breakthroughs in the 1960s, the cannabis plant and materials are being researched constantly in academic settings, hospitals, and research organizations. In Israel there are over 40,000 patients being treated with cannabis products and monitored accordingly. In addition, dozens of clinical trials are being performed each year.
The therapeutic potential of the Cannabis plant is enormous. It has been cultivated and used for thousands of years, and was found beneficial for several medical and mental conditions. The Cannabis plant contains hundreds of different compounds, some are medically proven while others aren’t, as well as endless combinations between them. The therapeutic potential is endless, requiring research and development capabilities, preclinical and clinical trials as well as big data analysis.
Part of the R&D in the cannabis industry relays on pharmaceutical research, development, analysis and models such as formulation, strength, bioavailability, PK, PD and more.
CAPA stands for corrective and preventive actions. CAPA action items should be defined and implemented. Corrective actions apply to immediate or short term actions that were taken in order to fix the problem. Preventive actions apply to prevent a recurrence of such deviation and to enable continuous improvement over time. To assure that the preventive actions were defined properly, we will assess retrospectively their effectiveness.
The risk arising from the deviation must be assessed carefully to assure product batch quality or any other materials associated with the deviation this can pose a risk for patient/user health and/or product quality and efficacy.
The initial description of the deviation is supposed to provide a background information regarding what exactly happened, how it was detected and what is the relevant information and parameters values that may assist in the root cause investigation. And that will enable us to identify in high assurance level, what really caused the problem.
The primary purpose of a deviation investigation handling procedure in a GMP environment is to first, identify and determine what the root cause for the deviation is and to demonstrate and specify which immediate corrective actions have been taken. After immediate corrective actions implementation, we would like to determine which preventive actions should be implemented in order to assure the deviation will not occur again and to enable continuous improvement in the organization.
Deviation investigation is part of the basics in GMP that assure final product safety, integrity, consistency and quality.
In practice, an investigation report should include deviation description, root cause analysis, impact assessment and CAPA (Corrective And Preventive Actions).
Deviation may alter product safety and quality and may put the patients/user in health and life risks. Any deviation that occurred at any stage of the cannabis product chain, must be reported, documented properly and thoroughly investigated.
Besides being a basic requirement in the GMP, deviation handling plays a key role in assuring quality, efficacy and safety of Cannabis products. And by establishing a proper investigation and CAPA mechanisms in your company, you can meet your business and regulatory challenges and supply a high quality Cannabis product in a constant manner.
Deviations are non-conformance situations which may occur as part of cloning, cultivation, manufacturing, storage and distribution processes. The non-conformances are usually in contradiction of an approved procedure, manufacturing instructions, specifications or standard. Deviations may occur along each step of the cannabis cultivation, manufacturing, storage and distribution chain. For example, equipment malfunction, improper storage conditions, wrong specific lab results, deviation in the extraction process, filling or packaging processes, wrong batch record, contamination and so on.
Adequate facilities, qualified systems and equipment, documentation, quality control, personnel training, deviations and customer complaints handling are only part of GMP basics that every cannabis grower and manufacturer should meet.
By implementing GMP in your Cannabis facility and establishing an effective quality system, you will ensure that all the processes are being conducted properly; all the employees know and understand their job. Maintaining an effective quality management system and GMP standards will assure cannabis products are safe for use and have the required efficacy, potency, purity, and can be sold in local and global regulated markets.
GMP stands for Good Manufacturing Practice. The GMP purpose is to assure that the manufactured products consistently meet the regulatory requirements for safety, identity, potency, quality, purity etc, thereby minimizing the risk for end users and patients.
The scope of GMP begins from post-harvest stages such as trimming, drying and storage and continues during the cannabis products manufacturing, filling and packaging. GMP’s main challenge is to build the highest quality into the cannabis product as part of the entire manufacturing processes. Beginning with selecting and qualifying raw material suppliers and ending in a safe product that meets all release specifications and has a proven shelf life.
Cannabis cultivation and production chain includes several stages that require control, standardization, defined procedures and good practices implementation. Activities such as cannabis mother plants cloning, cultivation, harvesting, post-harvest processing, product manufacturing, packaging, labeling, and distribution require different elements to be applied as part of these processes. For example, during cultivation, Good Agricultural Practices apply, whereas during distribution, Good Distribution Practices apply.
Validation for Cannabis growers, manufacturers and distributors will include at least:
- Growing, post harvest and manufacturing facilities and clean rooms
- HVAC systems
- Control and monitoring system
- Water, compressed air, process gases
- Manufacturing equipment and machinery
- Manufacturing process, Sensitization, sterilization and cleaning processes
- Filling Packaging and labeling processes
- Software and computerized systems
- Analytical system, equipment and methods
- Storage areas
- Supply chain
Validation is documented evidence with a high degree of assurance that demonstrate that a cannabis related system/facility/equipment/process/software/procedure/analytical method etc. comply with acceptance criteria and requirements.
The requirements are defined in a pre-approved validation protocols based on manufacturer specifications, customers process requirements, “Health authorities” regulatory requirements and Cannabis industry common practices.
Validation and qualification represent the effort to approve and assure reliability, quality, safety and efficacy of the cannabis product and can decrease significantly the quantities and costs of routine tests and analysis and increase reduce rejected product levels.
Cannabis facilities design should be based on the following:
- Proper location
- Minimizing risks from the outer environment
- Proper material and personnel flow
- Controlled areas where the raw material/intermediate and final product are being received, processed and stored
- Clean rooms where the raw material/intermediate and final product are exposed in order to avoid contamination and cross contamination
- Pressure cascade and interlocks between different areas in the facility in order to control air and contaminants flow direction
- Material and characteristics of the facility such as floor, panels and ceiling as well as material of construction of machinery.
- Manufacturing technology that will be in compliance with Good Engineering and Manufacturing practices
- Proper gowning and operation of employees in the facility
- Validation for utilities, manufacturing equipment, software, cleaning methods and quality control testing
- Control and monitoring of critical parameters and system that may have an impact on product quality and patient safety
Although the fact that cannabis is after all- a plant, Cannabis products which are being used by patients and/or consumer have to be safe, pure, and effective and meet the required quality level, just like other pharmaceutical, food, cosmetics products being sold and used globally.
Cannabis cultivation, processing and manufacturing facilities should be designed and operated based on Good Practices standards and regulations in order to be approved as an authorized/certified facility by the relevant regulatory body.
Facility compliance with GAP and GMP is only part of the job, but it is the basis that every Cannabis grower, manufacturer or distributor should have in order to be well positioned in the global regulated Cannabis industry.
In order to meet GACP regulations, the cannabis cultivation process, from propagation material until the trimmed dry flowers storage and distribution has to be standardized and controlled, documented and managed in a proper manner and in compliance with current GACP and GMP regulatory requirements. All activities in terms of cloning, growing, flowering, harvest, trimming, drying, curing, storage and transportation must be backup with written and approved procedures and employees should be trained accordingly. The dried flowers have to meet release specifications in terms of Cannabinoid content, degradation products, pesticide residuals, heavy metals, microbiology, toxins and sometimes more.
GACP stands for Good Agriculture and Collection Practices. The main challenge of the GACP is that the cultivation and post harvest facilities will be designed properly to minimize risks from the outer environment, to enable a correct personnel and material flow.
We want to avoid contamination of any kind, to improve the yield, to achieve the desired cannabinoid content, to optimize and control cultivation parameters and to meet the target market regulatory requirements.
When we want to use cannabis therapeutic benefits, as raw dried flowers or as source for Active Pharmaceutical Ingredients (API) to be used either by GMP manufacturers or by consumers/patients, we have to assure the dried cannabis flowers will meet safety, efficacy, consistency and quality standards.
The Cannabis cultivation area has been developing in the past decades and from <1% cannabinoids cannabis plants in the 70s, today we can achieve ~30% total cannabinoids content from THC and CBD to CBG, CBL, CBC, CBN, terpenes and other compounds. In order to increase the yield, decrease inconsistency and improve corp quality, growing and cultivation facilities are much more technological, controlled and regulated.
Cannabis is a plant, and by nature suppose to be genetically variable and to spread its genetics to different areas to survive over time. Also, as no fruit from the same apple tree taste the same, the same applies to the cannabis flowers in terms of Cannabinoids and terpenes composition and concentration.
Cannabis is a plant, and by nature suppose to be genetically variable and to spread its genetics to different areas to survive over time. Also, as no fruit from the same apple tree taste the same, the same applies to the cannabis flowers in terms of Cannabinoids and terpenes composition and concentration.
There are many different varieties of the cannabis plant. Hemp refers to the non-psychoactive (less than 1% THC) varieties of Cannabis sativa. Both hemp and cannabis come from the same cannabis species, but are genetically distinct and are further distinguished by use, chemical makeup, and cultivation methods. Today, hemp seeds and their oils can be found in breads, cookies, smoothies, pasta, yogurt and salad dressings. It’s a niche market, with a growing number of specialty outlets due to a growing understanding of this food’s nutritional benefits.
A diffusion barrier, which separates the circulating blood from the brain extracellular fluid in the central nervous system (CNS). The blood-brain barrier protects the central nervous system from potentially harmful chemicals while regulating the transport of essential molecules and maintaining a stable environment. The BBB is formed by highly specialized endothelial cells that line brain capillaries and transduce signals from the vascular system and from the brain.
Medical Cannabis/Marijuana product is a drug product which contains cannabis and/or active material from cannabis plants such as Cannabinoids and Terpenes that were approved for usage by the FDA/Eu or other health authorities.
Cannabis Sativa – an annual herbaceous plant in the Cannabis genus. It is a member of a small, but diverse family of the flowering plants. Cannabis Sativa is probably the most common form of cannabis worldwide and also the type with the most applications. Cannabis Sativa grows taller than the other types of cannabis, gaining height all through its vegetation and flowering phases.
Cannabis Indica – an annual plant in the Cannabis family. Cannabis Indica originated in the hash-making countries of the world like Pakistan, Afghanistan, and Morocco. Cannabis Indica is a more compact, thick-stemmed bush than the other types of cannabis.
Cannabinoids that occur naturally in the cannabis plant. When a patient consuming medical cannabis the phytocannabinoids interact with the body’s endocannabinoid system. This central regulatory system is known to affect bodily processes such as appetite, mood, and sleep. Without any external influence, the body naturally produces its own cannabinoids that bind to cannabinoid receptors in both the central nervous system and the peripheral nervous system. This existing internal infrastructure is what enables phytocannabinoids to provide such powerful benefits.
Fragrant oils that give cannabis plants and flowers their unique smell and aroma. These oils are secreted in the flower’s sticky resin glands, the same ones that produce THC, CBD, and other cannabinoids. Terpenes also can be found in many other herbs, fruits, and plants. When inhaled or ingested, the terpenes act as an assistant to cannabinoids as they work to penetrate the blood-brain barrier.
Is a drug for relieving distress in a terminally ill person in the last hours or days of a dying patient’s life. The palliative drug is usually given by a continuous intravenous or subcutaneous infusion. When it comes to medications for pain management, there are two categories: opioids, which dull pain systemically, throughout the body; and adjuvant analgesics, or helper medications that can target specific types of pain, often by fighting inflammation.
An organ or cell able to respond to light, heat, or other external stimulus and transmit a signal to a sensory nerve. Cannabinoid receptors, located throughout the body, are part of the Endocannabinoid system which is involved in a variety of physiological processes including appetite, pain-sensation, mood, and memory. CB1 and CB2 are two known subtypes of cannabinoid receptors.
CB-1 receptor – A cannabinoid receptor located primarily in the central and peripheral nervous system. The cannabinoid THC has been shown to possess a very high binding affinity with CB1 receptors. That is why consumption of cannabis strains and plants containing a high amount of THC result in a relatively potent effect, giving patients significant relief from pain, nausea, or depression.
CB-2 receptor – A cannabinoid receptor located predominantly in the immune system but also in the brain, peripheral nervous system, and gastrointestinal tract. CBD has affinity to CB-2 receptors
Cannabis tablets, Cannabis capsules, Cannabis soft-gels, Cannabis suppositories, Cannabis creams, Cannabis pastes, Cannabis patches, Cannabis inhalers, Cannabis oil etc.
Good Manufacturing Practices to be implemented as part of the Cannabis growing, drying, storage and medical cannabis products manufacturing, packaging and distribution. GMP or GxP standards are very common in the Pharmaceutical and Medical Devices industries and Medical Cannabis, as being used to treat patient, should meet these standards.
GMP in the Cannabis industry will assure the medical Cannabis products are safe for usage, has the efficacy to treat patient and meet quality requirements such as purity, strength, uniformity and identity.
Medical Marijuana/Cannabis products should meet strict quality standards such as GMP for medical Cannabis manufacturing practices, GSP for medical Cannabis storage and security practices, GCP for medical Cannabis clinical practices, GDP for medical Cannabis distribution practices etc.
There are two stages in the approval process to grow cannabis or cannabis products manufacture for medicinal purposes. The applications must be submitted to the medical cannabis unit authorized by the Ministry of Health or by the Ceo Ministry of Health. Medical cannabis manufacturers must present a business license, proving that their workers are professional and have relevant education and experience, the presence of professional functions such as quality assurance manager, QP, production manager approved by the medical cannabis unit.
See the article ” Control, Quality, GAP and GMP in the commercial growth of medicinal cannabis plants “.
See the article “GMP standard for medical cannabis products according to the Israeli Ministry of Health “.
pesticide residues, fertilization, and microorganisms, therefore considered superior and more effective for use for medical purposes.
The FDA recognizes that cannabis and medical cannabis products are effective and are used to treat a variety of diseases such as AIDS, epilepsy, chronic/neuropathic pain, spasms, cancer, and vomiting (as part of chemotherapy). Currently, the FDA does not allow the marketing of medical applications or product drug containing botanical cannabis since have not found this type of product to be safe and effective for any medical indication, except “Satibks” of the company GW which approved as a botanical drug.
The FDA has not approved any medicine containing marijuana plant as a botanical medicine except for Marinol and Syndrom. The FDA’s role is to carefully review the data submitted in the IND submission and determine whether the new drug considered safe and effective for the treatment of illness or medical condition and meets the regulatory requirements before it is approved.
The FDA has approved Marinol and Syndrom for medical use in the US These two drugs contain the active ingredient Dronabinol, a synthetic cannabinoid that is similar in its effect to THC, and another FDA-approved drug, Cesamet, Nabilone, which has a chemical structure similar to synthetic THC.
No. Cannabis products are not included in the definition of supplement according to chapter 201 (ff) (3) (B) (ii) of the FD & C act. If a raw material such as cannabidiol has been approved for use as a trial drug, it will require clinical trials.
The cannabis plant has more than 600 substances and compounds with healing potential. Some of these substances have a direct pharmacological effect, while others work together with the active ingredients, creating synergy and enhancing the product’s efficacy.
The cannabis plant has more than 600 substances and compounds with healing potential. Some of these substances have a direct pharmacological effect, while others work together with the active ingredients, creating synergy and enhancing the product’s efficacy.
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Product Development, Delivery System & Clinical Trials
Novel cannabis products and delivery system for improved bio-availability, accuracy, consistency and efficacy that can be proven and backed up with a strong IP and clinical trials
Growing, Manufacturing & Lab Facilities Design
Conceptual & detailed design including personnel/material flow diagram, pressure cascade, cleanness level, utilities and technology based on current GxP standards and common practices
Quality Assurance & Good Practices (GxP)
An effective quality management system establishment, policies and SOPs writing, cultivation and manufacturing procedures, protocols and employees training
Cultivation & Product Manufacturing Technology
Utilities, systems, machinery and controls required for cultivation, development and manufacturing processes that will enable high quality, control and cost-effectiveness.
New Product Regulations & Submissions
Cannabis products specifications and regulatory requirements completion including all relevant documentation and data in order to be submitted and sold in regulatory markets
Qualification &Validation
New facility, infrastructure, utilities, system, machinery, software, control system, manufacturing/cleaning processes qualification and validation protocols, execution and reports
GxP – New Standards For Cannabis Products Quality Assurance
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Cannabinoids Crystallization – doing it right!
What is the Crystallization of Cannabinoids? Crystallization is a process when molecules arranged into a well-defined, rigid crystal lattice to minimize their energetic state due to the fact that a [...]
Project Risk Management in the Cannabis Industry
Basics in Risk Management A project, no matter in which industry, is a set of interconnected tasks intended to achieve a certain goal, with a particular set of resources, [...]
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