Cannabis Procedures and SOP
Cannabis Procedures and SOP are central to the operations of any cultivation, extraction, processing, packaging or testing business. Startups who invest in solid standard operating procedures (SOP) are often several steps ahead, and don’t suffer any costly mistakes.
Cannabis SOP are required by each state where cannabis, marijuana or hemp are regulated:
Any cannabis, hemp, medical or adult-use (recreational) marijuana product is subject to a number of controls, from seed to shelf. NaturPro Scientific has supported a number of clients in the aim of providing safe, effective medicines for children and adults who need them.
Contact us to learn more about our services supporting the cannabis industry.
Some central turnkey services include:
- Regulatory Submissions and Licenses (License Development)
- Operations, Facility Inspection, Start-up, Staffing and Training
- Good Agricultural Practices (GAP), Certified Organic, Integrated Pest Management
- Procedures and SOP (Facilities, Hygiene, Sanitation, Training, Ingredients, Materials Specifications, Certificates of Analysis (COA), QC Inspection & Approval, Batch Records, Complaints, CAPA)
- Good Manufacturing Practices (GMP) Readiness and GMP Audits
- Extraction Processes (ethanol, supercritical, alkanes, BHO, solventless)
- Hazardous Materials Handling
- Advanced Formulations and Packaging
- Proprietary Formulas and Products, New Product Development
- Intellectual Property (IP) Development and Management
- Documentation, Records, Forms
- Analytical Test Method Development, Optimization and Validation
- Materials Testing and Verification
- Risk Assessment & Crisis Prevention and Management
NaturPro is Actively Involved in Standards Development for Cannabis & Hemp Products:
- Contributed to Cannabis Industry Standards Adopted by ASTM
- Serves on AHPA Cannabis Committee to Develop Industry Standards
- Reviewer of the newly updated updated Good Agricultural and Collection Practices (GACP) from AHPA
- Supporting the innovation and research aims of Blue Circle Development
Some of our FREE Articles on Cannabis and Medical Marijuana Procedures and Standards:
- Keys to Quality Control Testing of Botanical Products
- Opportunities to Improve Cannabis Dosing and Quality
- 10 Keys to Natural Product Development
The following article excerpt was published in Natural Products Insider in October, 2015:
Where the Cannabis and Hemp Market is Going
Ten percent of Americans use it at least “occasionally,” and its clinical data is stronger than that for many drugs. The safety and history of cannabis consumption is unparalleled as a natural product. Combined with the internet of cannabis anecdotal evidence, it’s hard to think of something that is so well researched, but so poorly understood.
In looking at a 2015 JAMA meta-analysis of 37 high-quality clinical trials on cannabis totaling 2,563 subjects, the eight trials that measured its effects on pain found it “very effective.” Evidence of cannabis’ benefits for nausea and vomiting was also found in three trials, mirroring its age-old use in folk medicines. The analysis also found cannabis was effective for spasticity in multiple sclerosis (MS), improving appetite in HIV/AIDS and wasting diseases, and ocular pressure in glaucoma.
Regardless, most cannabis patients don’t need a meta-analysis to know about the relief the medicine gives them. Like it or not, for so many people, cannabis improves physical, mental and emotional well-being during difficult or terminal health issues. And its use by normal, healthy people is overall a low public health risk compared to alternatives like alcohol. Thus, many believe access to cannabis products—that meet high standards—for both medical and recreational use should not be out of reach.
However, the value of cannabinoids in the clinic, as well as general use to simply support overall health and wellbeing, is often limited by its side effect profile. Adverse events noted in a small percentage of subjects consuming high-THC cannabis included dizziness, dry mouth, fatigue, euphoria, disorientation, drowsiness, confusion, loss of balance and hallucination. The use of high-THC products can be habit-forming, and it remains “unclear” whether the products are beneficial or harmful for people with schizophrenia.
Obviously, the stigma and well-known psychoactive effects of THC are no help for its cause. But many feel that a key reason widespread medical adoption of cannabis is stalled is that patients have simply been unable to accurately measure or control how much they consume. Mix in the development of ultra-potent strains over years of a black market, and the lack of requirements to analyze and control dosage forms under that system, and it’s no wonder that legitimate use of cannabis is questioned by many critics.
Recent work has attempted to control THC doses better than before, while studying the effects of various doses and combinations of cannabinoids. Today, many believe that controlled dosage forms of cannabinoids, including cannabidiol (CBD), are required for any real progress to maximize cannabis’ health benefits.
CBD is naturally found in higher concentrations in industrial hemp than in today’s marijuana. In fact, the use and acceptance of hemp medicinally for thousands of years could be as much due to the psychoactive effects of THC, as to the anti-inflammatory and balancing effects of CBD.
Medline lists 92 clinical studies with cannabidiol, in some cases on its own and in others combined with THC. The role of CBD in the new millenium is just starting to evolve, however its presence in “approved” medicines began in ancient times and ended in the early 1900s. During that time, cannabis health products were made from industrial hemp. Thus, we are fairly sure that cannabidiol is one very old dietary ingredient with a long period of consumption and safety, even if it lacks the type of marketing evidence required under the current regulatory constructs.
Under the category of “studies in healthy people,” CBD possesses a level of clinical evidence on par with some very well-studied dietary ingredients. CBD was most recently found effective in improving smoking cessation efforts and reducing anxiety in non-diseased populations, in multiple controlled clinical trials. A large area of study now is the use of CBD to reduce THC-induced mental impairment and cravings for drugs as well as food. Now, in states allowing use of medical cannabis for pain, a drastic drop in overdoses from painkillers is now becoming apparent. Needless to say, a large base of human data support the notion CBD-THC combinations could help to serve as the anti-gateway to more than just a box of donuts.
The other step to getting the dosage right is to have the proper analytical tools to measure it. In states where it is approved for use, all cannabis products are required to list test results from an approved lab on all product labels (representing a step up on food and supplement requirements), but the reliability of these test results have been questioned. In another recently published JAMA communication, 75 products from California, Colorado and Washington State were tested for cannabinoid content. Not surprisingly, 60 percent of products contained less THC than listed on the label, based on strict tolerance limits of +/- 10 percent. In the products tested, non-THC content including CBD was generally low.
Where are cannabis and hemp going? The cannabis experiment is leading to vibrant debate and rapid change, setting the stage for what is to come. Although many unanswered questions remain, we are starting to see the future of a natural, safe and effective health product that adheres to strict yet sensible standards.
The following article excerpt was published in Natural Products Insider in April, 2015:
Capsaicin, CBD and Cannabis: The Hot and Cool of Joint Care
Natural products for osteoarthritis continue to gain steam in the wake of pharma failures. Most recently, a February 2015 meta-analysis in the British Medical Journal showed that acetaminophen (a.k.a paracetamol) is not only ineffective for osteoarthritis pain, but also posses greater safety issues for the liver than originally thought has drawn somewhat of a deafening silence from the beaters of the evidence-based bible.
Both paracetamol and capsaicin are graded as “appropriate treatments” in the updated OARSI guidelines for osteoarthritis treatment. The anti-inflammatory effects of capsaicin continue to be evaluated on the meta-analysis and mechanistic levels, showing this compound—which puts the “hot” in “spicy-hot”—may have more clout and applications than originally thought. A new meta-analysis of topical capsaicin shows it to be effective for the treatment of osteoarthritis in various joints. In an animal model of autoimmune arthritis, capsaicin was recently found responsible for regulating a complex mechanism involving pain receptors, sensory nerves, and somatostatin release. In addition to being a potent TRPV-1 agonist, capsaicin was also recently found to interact with mu-opioid receptor, reflecting another possible therapeutic application for capsaicin.
Cannabis, the age-old medicine that’s now re-awakening from prohibition, offers some of the most potent pain relief benefits of any natural product known to man. In fact, this is the primary use of it in the burgeoning medical marijuana industry: more than 90% percent of Colorado medical cannabis patients have a physician’s approval to use cannabis specifically for severe or chronic pain, far outnumbering its use for other diagnosed medical conditions. While this number may be the result of over-reporting bias, the fact remains that cannabis (and especially particular strains) are considered by patients and physicians to be highly effective for pain.
Cannabidiol (CBD), found in small amounts in most strains of recreational cannabis, has potent and far-ranging anti-inflammatory effects. Today, optimized dose delivery forms are emerging to allow for its applications to populations with serious health concerns. Lest we forget, our prized psychoactive THC is a very potent analgesic as well, and together with CBD have a synergistic impact on pain. Standardized, sub-psychoactive doses of cannabis could potentially offer benefits for pain equal or superior to many NSAIDS. Not surprisingly, many in the mainstream medical establishment believe that deliberate, well-thought approaches to cannabis administration will emerge as part of accepted medical treatments for joint and other types of pain in the near future.