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GMP in the World of Cannabis

June 8, 2020

Cannabis is growing in popularity and usage around the world. Hemp which is related to medical cannabis has been used for over 8000 years in the production of fabrics and other commodities.  The first recorded medical use of cannabis was 4900 years ago in China, as an herbal therapy to treat pain. In the 19th century physicians in the USA used cannabis to treat headaches and insomnia, and it was added to the US Pharmacopeia as a potential treatment for neuralgia, tetanus, alcoholism, gout, and other disorders. When the Food and Drug Act was signed by President Theodore Roosevelt in 1906, cannabis was included along with alcohol and morphine. Through the roaring 20’s an effort to improve morality in the country various activities were banned such as prostitution, gambling, liquor, oral sex. During this time cannabis became stigmatized as immoral. Alcohol became prohibited, and 'marihuana' laws were passed making it illegal to grow or use it. The film “Reefer Madness” came out in 1936 as propaganda against the use of cannabis, depicting it as driving young people crazy. Hence cannabis gained the reputation as dangerous and toxic.   The marijuana Tax Act of 1937 was passed making it illegal and creating a perception of being immoral in America. Many years after, during the 1960’s, cannabis became more widely used recreationally, and limited research began to show some medical benefits.

Although the FDA approved a synthetic form of THC to treat nausea from chemotherapy, the DEA classified cannabis as a Schedule 1 drug alongside LSD, cocaine and heroin.  In the 1990’s scientists researched the human endocannabinoid system, finding that humans create neurotransmitters that bind to cannabinoid receptors in the brain and throughout the nervous system. These receptors modify processes in the body responsible for appetite, learning, pain sensation, and inflammatory response. The cannabinoids in the cannabis plant also interact with these receptors and have an impact on physiology and body function. The two most common cannabinoids are THC and CBD. THC is responsible for the psychoactive effects (commonly referred to as the “high”), while the CBD has a more physiological impact (reduction of pain and inflammation for example). There are many other compounds within cannabis and the levels of these compounds can be vastly different depending on strains and cultivation practices.

The effective use of cannabis by physicians as a medicine has been limited due to the limited scientific data available and the lack of regulatory controls today.  However, as society moves forward in legalizing its use and researchers continue to study its effects on the human body, based on what is already known, cannabis will inevitably become an important part of a physician’s toolbox in the treatment of a variety of illnesses and symptoms. Since the cannabinoids in cannabis are a product that comes from a plant, it is not synthesized and therefore not easy to control qualitatively and quantitatively. This puts a burden on the grower and manufacturer to demonstrate how they control the quality of their product.  

One of the greatest improvements that a cannabis marketer can do to promote confidence within the medical community and remove the barriers to cannabis usage is to ensure Quality is well controlled. In a way that is similar to pharmaceutical products, controls in place for cannabis production must reflect these basic principles. These principles can be wrapped up in what is known as GMP. Good Manufacturing Practices are applied in pharmaceutical companies and many other segments of our global economy as a means to demonstrate conformity of products to meeting standards of purity and strength. This means a lot when it comes to a chemical that we put in our body for the purpose of impacting its function in a positive way.

For the compounds in a plant product such as cannabis to be prescribed, a physician would need to know that the product contains a certain type of chemical that has a level of purity that can be defined and proven. One way to provide proof of quality is to conduct testing. A test of the final product can reveal some important information about its composition and purity; however, the chemical composition of a botanical is very complex making it impractical if not impossible to test for every chemical component. Therefore, the only way to give confidence in the quality of what has been produced is to ensure that all the production processes are done in a way that is controlled and repeatable. This means you remove sources of variation such as the variation from humans that can be unpredictable in performing a task, machinery that may not perform the same as it did yesterday, raw materials that may not be exactly the same as what was received a month ago, procedures that are not adequately defined to ensure consistent interpretation by multiple operators on different shifts. To achieve this, a manufacturer must follow a set of strict rules throughout the entire process of manufacture so that variation is eliminated, or at least minimized. Additionally, this variation must be the source of constant monitoring so that the manufacturer is always aware of what may be causing it, and the resulting deterioration in product quality.   All of these rules are collectively known as GMP (Good Manufacturing Practices).  

As an example and to clarify understanding, the controls generally associated with GMP include the following:

·        Management Commitment. Actions would include communication to employees, written policy supporting the quality system, daily actions that support GMP and product quality, regular meetings include a review of quality performance and compliance to GMP.

·        Well defined organizational structure with a Quality Unit that can act with independent authority

·        Document management system to ensure documents such as procedures and specifications are properly controlled

·        Personnel are provided the tools, training, environment that supports the requirements of GMP. This includes hygiene rules, controlled documents, adequate bathroom facilities, adequate facilities for breaks, and ergonomic considerations.

·        Training system to ensure employees are well trained and understand why they follow certain rules in executing the duties of their job

·        Changes are managed to ensure that a change does not have a negative impact on product quality

·        The processes are audited routinely to ensure everything is working as it should, and continues in a state of control that is predictable

·        A system of Corrective Actions is well organized to ensure that appropriate actions are taken when a nonconformity is identified, or a weakness is uncovered within the system

·        Testing is performed as prescribed in a well-defined system of material control. This applies to raw materials, package materials,intermediate products, and final product.

·        The Facility is managed to ensure equipment, utilities, and the environment are well maintained to support the operations inits quality missions

·        Equipment is well maintained to support the production of a product that meets defined specifications consistently. This includes preventive maintenance and calibration.

·        A system of managing product that does not conform to specification. This includes material storage rules, identification, investigation, documentation and records, corrective action.

·        Management of material storage. Defined areas well maintained, properly identified, with conditions that prevent mix-ups, deterioration and contamination.

·        Control of waste to avoid mixing with product or causing contamination

·        Management of subcontracting activities such as lab testing, contract filling or packing, pest control, calibration.

·        Management of deviations to ensure minimizing impact on product quality while ensuring mitigating actions are well defined and implemented

·        Complaints are handled properly to ensure adequate investigation, customer feedback, and implementation of any actions necessary to prevent re-occurrence. This includes evaluation over time to detect trends that can be analyzed resulting in actions that will prevent future failure.

By embracing these key elements with a GMP mindset, the producer can provide assurances to themselves as well as investors and customers that the product will always meet customer and regulatory requirements.  It provides a good business model for continuity within the industry and a robust capacity for meeting consumer demand within a regulated industry.

About the Author:

Steven Cooper is a Quality Professional with over 40 year’s experience in the pharmaceutical, cosmetic, and cannabis industry. He participated in authoring the ISO 22716 Cosmetic GMP which has become accepted globally as the GMP standard within the Cosmetic industry. Over many years he has implemented QMS (quality management systems) in large and small companies, achieving ISO 9001 and ISO 22716 certification in addition to compliance to 21CFR Part 210/211 and EU regulations for Pharmaceutical manufacturers. He is a certified ISO 9001 lead assessor, certified EFfCI Auditor, ASQ Certified Quality Engineer, Section Chair of ASQ Section 1515, Voting member of ASTM Committee D37 Cannabis, and a certified MBTI practitioner.

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